Product Safety Resume Samples

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CK
C Kihn
Celestino
Kihn
9400 Asa Harbor
Dallas
TX
+1 (555) 344 8862
9400 Asa Harbor
Dallas
TX
Phone
p +1 (555) 344 8862
Experience Experience
Los Angeles, CA
Product Safety Manager
Los Angeles, CA
Runolfsson and Sons
Los Angeles, CA
Product Safety Manager
  • Manage multiple, high-visibility projects simultaneously, including communication to executive leadership
  • Develop business solutions which ensure compliance with consumer product regulations
  • Manage multiple, high-visibility projects simultaneously, including communication to stakeholders and executive leadership
  • Perform safety audits
  • Act as single point of contact for safety engineering for product safety issues in case of incidents and accidents, report to product safety executive in such matters
  • Define, maintain and supervise the safety process in the responsible region according to BT directives and relevant norms and standards (e.g. EN 50126, EN50128, EN 50129, SIRF, CSM, TSIs, etc.)
  • Develop business solutions which ensure compliance with consumer product regulations within the region
Chicago, IL
North American Product Safety Manager
Chicago, IL
Ferry, Abbott and Smith
Chicago, IL
North American Product Safety Manager
  • This position works North American Safety Regulatory Compliance Manager as co-leaders of the NASI Safety Group and together they develop, update and enforce the Product Safety Escalation Process to Distributors, NAQA, SIA QE and Subaru Corp. QA
  • Monitor both distributor's field information, NHTSA and DOT information to quickly identify and isolate potential Subaru "safety" issues and prepare a Product Safety Alert. The Product Safety Alert indicates to NAQA, distributors and Subaru Corp QA that the investigation of the issue is Top Priority
  • The Safety Regulatory Compliance Manager proactively supports the action by providing safety notices and recalls of all OE's for similar incidences as well as any and all relative regulations
  • Continuously monitor new safety regulations to understand the implications of such regulations. With the NASRC Manager, update process and parameters and educate to the related groups
  • Meet face to face with NASI President and NAQA Directors and other staff to present the investigation results, and ensure that the Safety Group has all pertinent data to present the case to the CSO
  • Attend “Safety Committee” meetings to explain the issues and the background of the investigation, related issues from other OE’s, and other relevant information to support the findings
  • Product Safety Escalation Process and in conjunction with the Safety Regulatory Compliance Manager, prepare the Product Safety Action Alert and present to Distributor Top Management and Subaru Corp. CSO
present
Boston, MA
Senior Product Safety Manager
Boston, MA
Mayer-Koch
present
Boston, MA
Senior Product Safety Manager
present
  • Support quality/technical services/product creation testing departments in developing and issuing corporate policies and standard operating procedures
  • Provide help desk services for US Group entities developing products
  • Maintain and run the CPSIA Consumer Data Base according to the rules specified by the US CPSC and serve a respective main contact
  • Act as help desk for in-house departments in case of technical questions regarding the correct application of product safety standards
  • Closely track changes in regulations and special customer requests
  • Engage with the Legal Department and external parties to obtain actual information on legal developments related to product safety/conformity standards (e.g. safety in design, material composition, product marking, disclaimer and advertisement)
  • Support sourcing departments (technical services/quality/product creation testing) in establishing and maintaining systems for tracking supplier compliance with standards
Education Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Kaplan University
Bachelor’s Degree in Engineering
Skills Skills
  • Strong mentorship – Ability to educate and assist less experienced staff
  • Strong quantitative and analytical capability
  • Strong multi-tasking skills – Ability to balance and prioritize workload for a portfolio of projects
  • Strong communication – Ability to communicate technical information effectively within all levels of the organization
  • Strategic leadership – Ability to apply technical expertise to benefit the larger organization
  • Excellent communication skills, both written and oral
  • Licenses – Professional Engineer or other appropriate licenses and certifications
  • Experience as a team leader
  • Problem solver and forward thinker – Ability to analyze, disaggregate information in a structured way, identify core issues, and synthesize options moving forward to resolution. Also, the ability to predict future issues and concerns
  • Integrity and trust
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15 Product Safety resume templates

1

Senior Analyst, Product Safety & Regulations Resume Examples & Samples

  • Manage the process of product safety and regulatory protocol development, maintenance, and updates in accord with Gap Inc. policy and legal requirements in Gap Inc.’s global markets
  • For new protocols, utilize multiple sources to gather and evaluate information on product requirements that require testing for compliance. Maintain and update on regular schedule existing PSR protocols. Work closely with lab and other technical experts, as well as Product Integrity and Technical Team staff in market and the Sourcing Offices
  • Consult with the Product Safety and Regulatory (PSR) managers on policy for requirements on PSR protocols. Consult with Corporate Quality Management Managers to ensure alignment and consistency between safety/regulatory and quality/performance protocols for the same products or product types
  • Manage the PSR corporate relationship with Gap Inc.’s approved labs. Align with Sourcing Office staff overseeing lab testing abroad. Develop expertise in laboratory test methods and standards
  • Communicate requirements through established PSR channels
  • Provide protocol requirements in clear, timely written publications to Gap Inc. stakeholders in the Brands and Supply Chain. Contribute to related PSR publications as needed. Answer questions from stakeholders
  • Develop training materials and “cheat sheets” for business partners to roll-out new policies and understand basics
  • Participate in live training sessions
  • Special projects: Leverage skills to support additional priority PSR projects
  • Demonstrated knowledge of product testing
  • Conceptual and analytical ability to synthesize complex information and make policy recommendations
  • Strong communication, organizational, and project management skills
  • Working knowledge of apparel and/ or hardlines safety and regulatory requirements preferred
  • Strong MS Word, Excel, and PowerPoint
  • Must be able to travel 5% time
  • 3-4 years working in product safety, product standards, product testing or related technical field in which research and communication were a major responsibility
2

Avp Product Safety Americas Resume Examples & Samples

  • To manage a team of highly skilled technical professionals within the global organization in France
  • To mentor and develop current product safety teams
  • To manage the long term mission of the group in evaluating raw materials and the clinical trials on the finished products as well as the review of consumer events related to products
  • To work towards the harmonization of testing protocols and determinations of the necessary evaluations needed for raw materials and finished products
  • Follow US, Brazil & Latin American toxicology issues to identify those that may have local and global regulatory impacts (NTP testing program, CIR, RIFM, testing requirements of regulatory agencies)
  • Participate as a L’Oreal representative on PCPC and other external liaison task forces to monitor and address any safety-related issues as they arise
  • To assure raw materials approved for use comply with regulations in various countries and in compliance with corporate policies and guidelines
  • Minimum of ten years industry experience
  • Must have prior Leadership experience
  • Participation in various technical & liaison organizations within the industry
  • Excellent organizational skills and the ability to handle multiple tasks
  • Experience working in a Global Organization
  • Multi-lingual with Portuguese and French a plus
  • Must be legally eligible to work in the US on an on-going basis
3

Product Safety Failure Analysis Engineer Resume Examples & Samples

  • Executes advanced failure analysis, root cause identification, and determines corrective action recommendations for notebook, desktop, and tablet PC products
  • Leads risk assessments for safety and quality issues through independent analysis and consulting with safety and regulations teams
  • Leads cross-functional escalation teams to drive decisions and corrective actions for product escalations
  • Analyzes historical and failure analysis findings to determine trends for early identification of emerging product issues
  • Drives 8d resolution process with ODM and OEM suppliers
  • Communicates program progress, escalations, and issue analysis to product stakeholders
  • Collaborates with management, internal manufacturing teams, suppliers, and development partners to drive prevention to prevent issue re-occurrence in future products
  • Leads and provides guidance and mentoring to less-experienced staff members
  • Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, or equivalent education or experience
  • Experience in product safety and regulations, specifically for desktop, notebook, and tablet PC products
  • Program/project management experience, PMP certification a plus
  • Expertise in the area of product safety and regulations, specifically for desktop, notebook, and tablet PC products
  • Demonstrated ability to troubleshoot, root-cause and mitigate safety issues on PC products
  • Advanced knowledge in the field of PC architecture
  • In-depth and hands-on experience in PC teardown, failure and root cause analysis
  • Extensive experience using engineering tools and software packages to test, design, and evaluate PC and tablet products
  • Previous experience leading escalation and/or issue resolution teams
  • Ability to quickly learn new subject areas and develop expertise, take on new assignments
  • Excellent written and verbal communication skills; mastery in English
  • Ability to effectively communicate program plans, proposals, and results to stakeholders including senior management levels
4

Product Safety Manager Resume Examples & Samples

  • To organize assessments, visits, trainings and workshops to supply chain in region (including all stake holders) which will help understanding LS&Co.’s product safety standards. Initiate necessary corrective actions and follow-ups as and when required. Provide product failure resolution, disposition of units, contractor chargeback and quality remediation
  • Align LS SAS apparels and non-apparel (accessories) supply chain to LS&Co. global product safety requirement
  • Identify, assess, qualify and monitor RSL and YW testing service providers
  • As part of the Centre of Excellence to help the product safety team to define the way of working for the operational team in regards to product safety
  • Partner with SO, SI and P&R to implement development and field works
  • Partner with regional QA managers to effectively execute the test protocol
5

Product Safety Resume Examples & Samples

  • Manage the company's product safety and compliance program to ensure that the organization is in regulatory compliance in the following areas: CPSIA (Consumer Product Safety Improvement Act), RSL (Restricted Substances List), REACH (Registration, Evaluation, Authorization & Restriction of Chemicals)
  • Provide expertise and guidance to management in interpreting all applicable governmental regulations (CPSC, European Union, etc.) and internal policies to ensure compliance
  • Provides follow-up support relating to request for validation of compliance from governmental bodies or customers regarding RSL, test results or other specific documentation relevant to the product
  • Acts as the company's representative for external communication, association and government meetings and legislation
  • Manages the Product Testing Program with nominated source(s). Establishes plan to ensure that all trims, raw materials and finished garment and footwear styles are tested and meet ONE Jeanswear Group' performance standards as well as all applicable CPSC rules, bans, standards and regulations
  • Monitors compliance and performance. Presents and regularly distributes performance trend information. Develops and drives corrective and preventive action plans with Materials/Trims/Development based on performance metric
  • Provides Company, Departmental and external training documentation and compliance including data consolidation, compliance checks and reporting. Each of these activities may include file maintenance, customer communication, meeting facilitation, Supplier/ Customer related responses
  • Provides technical support to company associates and external partners about product safety compliance program, regulatory requirements and implementation advice
  • Creates, reviews and modifies documents within area of responsibility and authority
  • Develops teamwork approach and generates cross-functional communication between Product Safety and sourcing departments
  • Develops new improvement initiatives and wins fellow Development, Production, Sourcing, Risk Management and Legal counterparts' participation and support. Networks, communicates and shares best practices
  • At least 5 years experience in quality assurance
  • In lieu of degree, 10 years or more experience in quality assurance/product integrity in apparel and/or footwear manufacturing
  • Candidate should be familiar with CPSC rules, bans, standards and regulations for apparel product, REACH, product testing, various QC processes/procedures, etc
  • Strong apparel or footwear manufacturing knowledge (patterns, trims, finishes, raw materials, sewing & embellishment)
  • Strong background in quality processes and systems
  • Strong analytical skills, attention to detail, and follow up
  • Ability to prioritize and organize multiple tasks
  • Excellent communication skills with solid people skills and a real team player approach
  • Ability to work well with multiple personality types and levels
  • Must have knowledge of a variety of computer software applications in word processing, spreadsheets, database and presentation software (MSWord, Excel, Outlook)
  • Ability to travel approximately 10% of time
6

Senior Manager Product Safety A&G Resume Examples & Samples

  • A-01 Representative for A&G Global Quality
  • Ensure CPSIA/A-01 database implementation and monitoring for A&G is guaranteed
  • Attend all product safety workshops and summits representing A&G as a member of Product Safety Task Force Group
  • Support and implement a proper NOCSAE testing process
  • Update existing and establish new specifications and test processes and where necessary to ensure they meet the required quality and performance levels of the finished product
  • Manage the Headquarter laboratory (HQ lab) activities, lead the A&G Lab team and guide the LO-teams & T1 suppliers for A&G testing
  • Ensure that all material and product lab testing at HQ lab and at all LO lab’s is accurate and in line with established adidas procedures
  • Execute annual on-site lab audits at all T1 suppliers
  • Create a monthly report of the Headquarter A&G Lab testing activities to be delivered to Director Sourcing
  • Maintain clear & consistent communications with all LO lab managers and provide them with precise guidelines regarding quality standards
  • Represent the company at external technical associations/committees dealing with product standardizations and norms in coordination with SEA and Product Management (e.g. DIN, TÜV, SEI, NOCSAE)
  • Fundamental chemical background
  • Good understanding of product safety within consumer product environment
  • Able to translate legal requirements on chemicals and substances into Adidas products
  • Is able to manage people
  • Minimum bachelor in Chemical engineering
  • 5-10 years of experience in similar industry (test institute) or task
7

Product Safety Manager Fabric & Apparel Resume Examples & Samples

  • Support the Product Safety team in creation, distribution and execution of Product Safety policies, projects and programs
  • Observe legal developments related to chemical/mechanical safety of products and packaging applicable for company products and services
  • Closely liaise with the Legal Department, Operations, Quality and Technical Services teams and Social & Environmental Affairs to support the development and updates of corporate policies and operating procedures related to product safety
  • Liaise with product safety managers from other regions to ensure utmost consistency in the roll-out and application of product safety standards
  • Communicate relevant standards, requirements and policies to internal departments for further distribution to suppliers
  • Support sourcing departments (technical services/quality) in establishing and maintaining systems for tracking supplier compliance with standards
8

Product Safety Analyst Resume Examples & Samples

  • Develop and maintain a framework to monitor and update laws and regulations that impact VF products and assist Sr. Manager, Product Stewardship in planning VF’s response to applicable laws
  • File product stewardship reports annually or as required by government agencies, ensure the reports are updated as required, are accurate reported on time to meet deadlines mandated by Laws and Regulations
  • Manage targeted restricted substance testing data, corrective action plans and report KPIs. Maintain product compliance information and assist Global Responsible Sourcing team in creating newsletters
  • Support the Product Safety Specialist to create and manage product safety documentation such as product safety bulletins, non-compliance case report and vendor surveys
  • Develop and manage an efficient global data collection process for the Product Stewardship Team. Maintain list of vendors, factories and suppliers, in collaboration with VF’s Sustainable Operations and Product Traceability & Responsible Materials teams to ensure accurate vendor/factory information is constantly available
  • Identify strategic questions to be asked and develop insights based on available data. Use statistical analysis software (SPSS, SAS, Excel, etc.) to conduct operational and strategic analysis on data collected
  • Develop and own a cadence for monthly and quarterly reporting/KPIs. Tell clear, concise, and insightful stories from your analysis to various internal and external audiences
  • Continuously improve analysis and reporting system by soliciting feedback from colleagues. Lead strategic analysis projects for the global Product Stewardship Team
  • Develop conflict minerals program plan annually, work with service provider to document the implementation and execution process and maintain all relevant business processes documentation for audit-readiness
  • Coordinate Conflict Mineral due diligence efforts with service provider. Ensure VF’s sourcing teams engage with vendor when due diligence data gaps are identified. Generate periodic reports on conflict minerals due diligence completion status and report KPIs to key internal stakeholders
  • 5 years experience in data analysis or related field(candidates with less experience but with proven ability will also be considered)
  • 2+ years supervisory experience preferred
  • BA/BS in Data Science & Analysis, Business, Economics, Finance or related field required
  • Exceptional analytical skills & attention for detail
  • Excellent visual design skills
  • Excellent Microsoft Office Suite skills (PowerPoint, Excel, Word)
  • Excellent SPSS/ SAS skills
  • Apparel and Footwear Product Safety and Supply Chain experience
9

CCS Product Safety Manager Resume Examples & Samples

  • Work closely with BU product safety officers and PASS councils to implement policies and processes
  • Interface with BUs to ensure product safety incidents are promptly and thoroughly resolved
  • Consult with BUs on the implementation and deployment of pro-active measures relevant to the business
  • Schedule and facilitate WHQ PASS council reviews
  • Provide technical expertise to BUs related to product safety
  • Track and report product safety metrics
  • Conduct product safety reviews on product development programs to ensure compliance to processes
  • Deploy processes in BUs to ensure regulatory compliance, focused on REACH and RoHs and other measures broadly impacting the business
  • Support Product Safety Officer in interactions with UTC on product safety matters
10

Product Safety Risk Analyst Resume Examples & Samples

  • Work with investigation teams to identify information gathering requirements, needed testing and/or sampling, and affected populations for safety issues
  • Construct models to assess risk using Continued Airworthiness Assessment Methodology (Ref. FAA AC39.8)-consistent techniques for unaddressed / uncorrected issues and to evaluate effectiveness of possible Corrective Action Plans
  • Assist in the development of standardized models, research historical data to support severity advancement
  • Experience working with engineers and other technical people on related areas of problem solving
  • Have well-developed writing and presenting skills
  • Be familiar with industry standard statistical packages such as Minitab or equivalent; comfortable with standard spreadsheet development as used by engineers and others engaged in analysis
  • Extensive Weibull / Weibayes probability analysis techniques and direct application experience
  • Be familiar with standard techniques used in Statistical Process Control, Quality Engineering related items, Reliability and Risk analysis, Design of Experiments, Life data analysis, sampling, and Monte Carlo simulation
  • Have the ability to work as part of a team or as an individual contributor; ability to exercise leadership on technical matters, for example in identifying where statistics can be used successfully
  • Adaptability to address business critical and time-urgent analytical needs with sound technical judgment
  • Product development and IPD experience
  • Experience developing system safety assessments for complex integrated products
11

Team Lead / Director Product Safety Resume Examples & Samples

  • You are the central contact person for all product safety matters; internally towards Product Management, Purchasing, Legal and PR department and externally towards the German Authorities, relevant NGOs, working groups and task force of the industry and external suppliers
  • You are responsible for the process management and external stakeholder-management (in collaboration with the Legal and PR department) in all cases where product safety is at risk, including executing callbacks
  • You are in charge of developing standards for product safety as well as product requirements by monitoring legal requirements and changes, relevant newsletters of NGOs, the industry or any other relevant sources to be aware of early warnings and using this information for ongoing enhancement and updates of the in-house Restricted Substances List (RSL)
  • You will enhance, standardize and monitor quality processes internally, interact with suppliers and manage 3rd parties, e.g. laboratories
  • You are responsible for hazard analysis, seasonal reviews and developing corrective action plans
  • You ensure the implementation of quality and product safety standards by our suppliers globally
  • You support and educate our suppliers in terms of product safety, restricted substances, REACh and other valid requirements ( e.g. recommendations by BFR, CADS, etc)
  • You lead and develop a team of 10+4 people
  • You closely collaborate with and provide guidance to linked departments (such as Product Management, Purchasing, Product Development, Vendor Management and Sustainability)
  • You participate and drive internal projects in Quality- and Supply Chain Management
  • Boredom doesn't get a look in here! Zalando is a working environment where something new happens every day
  • A corporate culture where your skills are judged only by your results – our motto: wear sneakers, not ties
  • A dynamic and highly motivated international team of experts to inspire and support you
  • The security of an expanding company with more than 10,000 employees and a company pension scheme
12

Manager, Product Safety Resume Examples & Samples

  • BS in biology, chemistry, cosmetic science, toxicology, or medical technology
  • Minimum of 8 years experience
  • Office environment for computer based research on Safety related issues
  • 8+ years experience in the development of cosmetic formulations
  • Familiarity with cosmetic raw materials and components
  • Familiarity with medical testing protocols and interpretation of medical test data
  • Thorough knowledge of Microsoft Office applications, RDS searches, and data mining techniques
  • Superior interpersonal/communication skills; Detail oriented
13

Product Safety & Risk Leader Resume Examples & Samples

  • Prior experience working in certification agencies
  • Familiarity with ISO, FDA and other regulatory standards
  • Experience with conflict resolution
  • Experience with entire NPI cycle of GEHC products
  • Familiarity with 510k submission process
14

Product Safety Risk Analyst Resume Examples & Samples

  • Society for Maintenance & Reliability Professionals
  • Certified Maintenance and Reliability Professional
  • ASQ Reliability Engineering Certification
15

Product Safety Risk Analyst Resume Examples & Samples

  • Perform quantitative safety risk assessments on gas turbine propulsion system flight safety hazards
  • Develop quantitative models blending engineering insights and statistical methods to determine required actions
  • Contribute to team responsible for sustaining world class safety of our product
  • Provide leadership for safety issue tracking process including performance metrics to ensure actions sustain safety of our products
  • 5+ years related industry experience in aviation or safety management
16

Clinician, Product Safety & Performance Resume Examples & Samples

  • Adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate are required
  • In depth knowledge of medical terminology is strongly preferred
  • Experience using vascular interventional devices is preferred
  • Regulatory Affairs/ Quality Assurance or complaint handling experience in pharmaceuticals or medical devices is preferred
  • Understanding of statistical fundamentals is preferred
  • Experience with health hazard evaluations is preferred
  • Experience interacting with the FDA, ISO, and/or Other Regulatory Authorities is required
  • Excellent communications and analytical skills are required.Medical Affairs
17

Lead Product Safety & Reliability Engineer Resume Examples & Samples

  • Is compatible with the infrastructure/environment,
  • Is demonstrably compliant with contractual and legal requirements and
  • Is acceptable with respect to the product safety and reliability
  • Development, Maintenance and Operation of a detailed plan and budget
  • Day to day coordination and direction of subordinate staff, both local and remote, on assigned project activities and output through to formal acceptance and operational experience
  • Day to day coordination and direction of subordinate staff on assigned project activities and output through to formal acceptance and operational experience
  • Performance of safety and reliability activities on a project
  • Participate and lead on the development and production of processes for the management of safety and reliability, and ensure all future development of corporate objectives are aligned and acceptable
  • Engineering/Scientific Degree and Professional Organisation Membership
  • Sound understanding of concepts and procedures in product safety and a good knowledge in related disciplines, including
  • Failure Modes and Effects Analysis
  • Fault Tree Analysis Methodology
  • Hazard and operability (HAZOP)
  • Systems Integration experience and System Architectural understanding required
  • Very good team leadership skills
18

Senior Product Safety Team Project Manager Resume Examples & Samples

  • In partnership with PST Lead, shape the PST strategic priorities and drive implementation by applying strong understanding of Therapeutic Area, regulatory science, signal management & project management to influence characterization of the compound/product safety & effectiveness profile. This responsibility will be accomplished through building and nurturing strong and trusted relationship with the PST Lead
  • In partnership with the PST Lead, manage multiple complex Product Safety Teams across multiple Therapeutic Areas and across all phases of the product lifecycle. This includes meeting planning and facilitation, meeting minutes documentation and post-meeting/general team management activities. Increase meeting productivity and advance decision-making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactive-ness, curiosity and active engagement. Drive strategic partnership with assigned Operations Manager. Mentor, coach and train less experienced PST PMs
  • Proactively utilize experience and knowledge to support the PST Lead in framing safety issues and making decisions. Anticipate possible outcomes of safety issues and provide guidance to the PST Lead so that he/she can be proactively prepared. Systematically analyze the impact of safety decisions and connect the dots across other decisions, discussions and actions across the organization. Communicate perspectives to PST Lead and recommend solutions
  • In partnership with PST Lead, manage escalation of safety issues and decisions to management and Safety Review Board (SRB). Create escalation documentation (e.g. SRB presentations) and help prepare the PST Leads for discussions. Manage the close-out of SRB action items for assigned PSTs. Coach PMs and PST Leads on best practices in engaging with the SRB in order to achieve optimal outcomes
  • Support the PST Lead in strengthening internal partnership/influence and establish role as the company leader of safety issues related to their compounds/products. Identify new opportunities for the PST Lead to build relationships and present thought leadership to peers. Identify and share best practices that other PMs can adopt to support their PST Leads. Represent the PST Lead and PST decisions in other committees/meetings
  • Support the PST Lead in strengthening external engagement/presence by providing recommendations on channels for expanding external engagement including topic ideas for publications, conferences to present at, key industry relationships to develop, etc. Provide significant contributions to the creation of content for external engagement activities
  • Proactively promotes best practice and knowledge sharing across PSTs. Shares PST best practices with other PM teams across AbbVie and seeks to learn and adopt their best practices. Acts as a champion within the PST PM organization and mentors other PMs to adopt best practices. Provides coaching and training on process excellence tools, skills, mindset, ways of working and behavior. Champion continuous improvement opportunities for the PST to establish agile and high performing PSTs
  • Drive timely development of key PST deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements, and connect the dots
  • Drive inspection /audit readiness activities and act as a subject matter expert during inspections/audits. Engage in leading and addressing PST-related inspection/audit activities and leading CAPAs/commitments
  • Ensure safety deliverable timeliness and quality levels are met through addressing alignment, consistency and data integrity
  • Bachelor’s degree in a healthcare discipline required (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines)
  • Masters or advanced degree is desirable
  • At least 7 years’ experience working in the healthcare industry and a strong understanding of the drug development process. Experience within Pharmacovigilance is desirable but not required
  • Understanding of the connections between regulations and science for the benefit of drug safety
  • Understanding of tools, standards and approaches used to efficiently evaluate drug safety, is desirable but not required
  • At least 7 years hands-on project management experience in leading cross-functional projects within a global company. Hands-on experience applying project management tools and templates
  • Experience in working directly with and influencing senior management including functional heads
  • Demonstrated effectiveness in working in multidisciplinary, matrix team situation, and demonstrated ability to manage change
  • Proven leadership and communication skills that minimally include: Effective and timely communication of project objectives, issues/risks as well as other project information required to keep the team and management informed
  • Ability to adapt in a quickly changing environment, ability to engage team members across functions to facilitate information sharing in order to maintain a continuous flow of information; capability to clearly present, influence, and logically justify positions/proposals; sound judgment; manages conflict and negotiation constructively; ability to develop build strong working relationships to enable high performing teams
19

Manager, Product Safety & Regulation Resume Examples & Samples

  • Ensure that the requirements ofchemical and product safety legislation for BASF products are fulfilled in therelevant geographical area. Implement BASF Group Product Safety Guidelines andDirectives
  • Develop and implement compliancestrategies for relevant BU. Steer cross regional, functional and countries soas to establish processes and tools to ensure compliance
  • Lead team members to deliverprofessional PS&R services to business and customers. Deliver effective andefficient services
  • Lead product stewardship in relevantgeographical area
  • Orchestra advocacy. Represent BASF atindustry associations and interaction with authorities. Provide guidance andtraining on all advocacy programs for country organizations
  • Act as governance. Provide guidance andservices to business units and corporate functions in chemical and productsafety legal compliance activities
  • Identify and communicate chemical legalrequirements that may affect BASF operations in relevant geographical area
20

Engineer, Product Safety Test Resume Examples & Samples

  • Independently conduct product safety/certification testing and evaluation of Rockwell Automation products with respect to third party safety (UL, CSA, ATEX). Demonstrate test to safety agency and preparing test document
  • Provide technical support to designers & Product Certification engineers of new products regarding third party safety agency requirements and related processes
  • Conduct EMC/EMI/ESD testing and other environmental testings
  • Able to interprets safety, environmental and EMC standard
  • Guide certification issues, functional quality and general product integrity
  • Assist and participate in lab management and lab quality system
  • Degree in Electrical or Electronics Engineering or related qualification
  • Advantages for those with experience in product certification testing for UL, CSA, IEC, EN and CE standards and requirements
  • Ability to carry out product testing for Environmental Test and EMC Tests
  • Ability to wire up a product test setup; create documentation/test report and possess good soldering skills
  • Basic software skills (Ladder Logic, C Language)
  • Experience with design analysis tools: Schematic capture and PCB layout
  • Able to analyze schematic diagrams, product specification and create test plan accordingly
  • Work independently with minimum guidance provided
21

Senior Manager, Consumer Product Safety Resume Examples & Samples

  • Ensure that regulatory requirements are met for new products and support other functions such as Retail, Seller Support, Product Quality, Customer Service, and Legal
  • Develop best-in-class processes and systems, and drive continual improvement
  • Drive scalable business solutions which ensure compliance with consumer product regulations
  • Proven ability to manage large and complicated projects
  • Knowledge of product compliance processes and the interplay with global supply chains
  • Bachelor's degree required with a scientific or technical focus
  • 10+ years of experience leading and developing teams
  • 10+ years of experience in Quality Assurance, Food Safety, Dangerous Goods/Hazmat, Regulatory Compliance and/or Product Development
  • Specific knowledge and experience in Consumer product safety regulations and standards such as ASTM/CEN/ISO/UL committees or working groups
  • Must be able to use Excel, Word and other common desktop software applications. Must also be comfortable learning web applications and proprietary software
  • MBA or Graduate Degree in relevant Technical Field
  • Experience leading international teams
  • Proven ability to work collaboratively both cross-functionally and vertically within an organization
  • Effective verbal communication, confident presentation style and excellent document preparation skills
  • Effective people leader with proven track record of hiring and developing the best talent, and getting game-changing work done through others
  • Ability to think critically about risk management and develop effective loss prevention solutions that meet business objectives
  • Self-starter who can work objectively with integrity and exercise sound business judgment and lead and influence others to do the same
  • Resilient and able to thrive and lead in a fast paced, entrepreneurial environment
22

Product Safety Manager Resume Examples & Samples

  • Lead team of Product Safety Analysts and Program Managers to complete daily activities on unsafe products and build technology to improve efficiency and scalability
  • Partner with business owners across organizations to define strategy, requirements, and timelines for major product safety initiatives
  • Manage multiple, high-visibility projects simultaneously, including communication to executive leadership
  • Develop business solutions which ensure compliance with consumer product regulations
  • 5-7 years of experience and demonstrated success in leading and developing teams
  • Working knowledge of lean six sigma and/or comparable process improvement methodologies
  • Must be able to use Excel, Word and other common desktop software applications; must also be comfortable learning web applications and proprietary software
  • Experience partnering with software development teams to build new technology
  • Knowledge of product compliance processes and interplay with global supply chains
  • Previous experience in tech, electronics, consumer goods, or other fast-paced, technology- driven businesses a strong plus
  • MBA or Masters/PhD in technical field
  • Demonstrated collaborative skills and ability to work well within a team and achieve critical deadlines
23

Senior Product Safety Engineer Resume Examples & Samples

  • Will provide day-to-day consultation for R&D and Operations to ensure safety compliance
  • Will conduct safety testing on existing and new products to ensure safety compliance
  • Will conduct Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) testing on existing and new products to ensure safety compliance
  • Will provide support to test houses during product evaluations
  • Will interact with outside agencies during internal audits
  • May interact with external manufacturing locations during agency audits
  • May work with other divisions to ensure safety compliance
  • Will create and maintain appropriate job related documentation
  • Will submit periodic reports on assigned topics to supervisor
  • May interact, telephonically, with customers to resolve product issues
  • Demonstrate ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), Power tools and test/inspection equipment
  • Demonstrate mechanical/electrical problem solving skills
  • 2-4 years related engineering experience
  • B.S. in electrical engineering or related curriculum
  • Associate Degree in electrical technology or related curriculum
24

JP Product Safety Risk Manager Resume Examples & Samples

  • Five years project management experience and demonstrated success
  • Experience driving process improvement with technology
  • Certification and experience in Product safety compliance in consumer goods, electronic appliances
  • Accomplished range of skills from high-level strategic thinking to creative and detailed execution
  • Self-motivated with critical attention to detail, deadlines and reporting
25

Product Safety Business Analyst Resume Examples & Samples

  • Work with the Product Safety team to define and initiate automation projects that streamline our ability to source and deliver products anywhere in the world
  • Clearly communicate goals, responsibilities, issues and status to team members and stakeholders
  • Drive effective teamwork, collaboration and commitment across multiple disparate local and remote groups with competing priorities
  • Bachelor’s degree in Math, Statistics, Computer Science, Business, Finance or any related field from an accredited institution
  • 1+ years of experience as a Business/Financial Analyst, BI Engineer or Systems Analyst preferably in an internet-based company with large, complex data sources
  • 2+ years of experience with Oracle SQL, MySQL skills and mastery of Excel
  • Advanced degree in Business Administration, Math, Computer Science, Statistics, Finance, or any related field from an accredited institution
  • Experience developing insights across various areas of customer-related data: financial, product and marketing
  • High levels of integrity and discretion in handling confidential information
  • Experience working in a lean, successful start-up or on a new product team where continuous innovation is desired and ambiguity is the norm
  • A clear passion for learning new business analysis techniques independently and continuously
  • Ability to work effectively with Data Engineers and BI Engineers to mine the right data sources efficiently and accurately
  • Proven analytical and quantitative skills and an ability to use hard data and metrics to back up assumptions, develop business cases, and complete root cause/ analyses
  • Ability to prioritize multiple concurrent projects while still delivering timely and accurate results
  • Strong verbal and written communications skills at an executive level that enable you to explain complex insights with clarity and precision
26

Product Safety Product Inspections Program Manager Resume Examples & Samples

  • Assess costs, benefits and risks; anticipate bottlenecks; identify, track and mitigate issues; manage escalations; anticipate and make tradeoffs; and balance business needs with technical constraints
  • 4+ years of Program Management experience in a related industry
  • Bachelor's degree in Engineering, Environmental or related field
  • Ability to influence cross functional teams of developers, designers, product managers, etc
  • Ability to do complex data analysis
  • Direct experience with US consumer product regulations (CPSIA, FDA, FCC, FTC, EPA) and testing processes
  • Demonstrated ability for being detail-oriented, self-motivated and driving follow-through on projects
  • Must be able and willing to think and act strategically and tactically
  • Master’s degree or equivalent experience in Environmental Systems, or related field
  • Ability to communicate appropriately and effectively with both technical and non-technical individuals
  • Detail oriented, yet able to look at a wide array of choices and identify what truly matters
  • A proven track record of delivering initiatives from conception through completion on time, within budget and on or beyond scope
27

Product Safety Analyst Resume Examples & Samples

  • Experience working with large data sets
  • Experience with Excel, Word, and other common desktop software applications. Must also be comfortable learning web applications and proprietary software
  • MBA or related advanced degree
28

Product Safety Manager Resume Examples & Samples

  • Bachelor degree or above as medical/pharmacy background/nurse or as equal
  • Customer orientation
  • Good communication
  • Positive and flexible
  • Fluency in both written & spoken English
29

JP Product Safety Risk Specialist for Consumables Resume Examples & Samples

  • Focus on Amazon’s operations for both supply and customer. The primary goal is to ensure regulatory requirements met
  • Lead efforts to ensure regulatory and operational compliance inspection of all incoming new products of consumer goods
  • Assess the risk of consumer goods products proactively to protect customers
  • Collaboratively work with the external authorities and establish a scheme to ensure product safety at JP Amazon market place for consumer goods
  • Design, implement, and maintain Product Safety specific processes that interface with operations and carriers such as classification databases, restriction databases
  • As the volume, diversity of products and partnerships grow, the Product Safety Risk specialist must be able to leverage resources and work effectively across functions
  • Bachelor’s Degree, the best preferable experience is registration of new consumable product to Ministry of Health Labor and Welfare
  • 5+ years Product Safety/Compliance, Hazmat, legal or related environment
  • A mix of compliance and program management experience
  • Specific knowledge and/or experience with JP and international regulations (Waste Management Regulations, etc.)
  • Specific knowledge of Consumer product compliance/safety regulations, drug, cosmetic regulations and environmental regulations
  • Develops and maintains good working relationships with others. Treats others with respect. Builds trust and rapport. Practices and promotes involvement and cooperation
  • Results Orientated: Must have a strong drive for results and the ability to thrive in ambiguity, enjoy learning vast avenues of business functions and vendor/ manufacturer/ customer relations, and the creative use of scare resources
  • Bachelor’s Degree, the best preferable experience is consumer goods (Cosmetics, Health care, Baby Care, Feminine Care, Hair Care, Fabric and Home Care, glooming)
  • Knowledge of KAIZEN, Six sigma green/ black belt
  • Basic Knowledge of problem solving methods such like KT (Kepner Tregoe) method
  • Basic knowledge of the JP Pharmaceutical Affairs Law
  • Registration of a drug product/ cosmetic products. Design or conduct testing for filing
30

JP Product Safety Risk Specialist for Electronic Appliances Resume Examples & Samples

  • Lead efforts to ensure regulatory and operational compliance inspection of all incoming new products of electronic appliances
  • Collaboratively work with the external authorities and establish a scheme to ensure product safety at JP Amazon market place for electronic appliances
  • Drive and document Product Safety issues within the company based on customer complaints/customer reviews and customer service follow-ups
  • Progress the optimization of FC processes and enhance competitive advantage and the customer experience
  • As the volume and diversity of products and partnerships grow, the Product Safety Risk specialist must be able to leverage resources and work effectively across functions
  • Based in Tokyo Meguro
  • Bachelor’s Degree, Development engineer or sales engineer of electronic equipment
  • Quality Control and Quality system management
  • Specific knowledge and/or experience with JP and international regulations (Electrical Appliance and Material Safety Law, Waste Management Regulations, Radio Act, etc.)
  • Technical Expertise, creative approach to system and process solutions; advanced. Computer literacy (Access, Excel, PowerPoint, Outlook, Word); Data-warehouse tables
  • Communication: Strong written and oral communication skills in both English and Japanese. Writes, speaks and presents information effectively, clearly, and with brevity
  • Bachelor’s Degree, the best preferable experience is notification of electronic appliances to Ministry of Economy, Trade and Industry
31

Product Safety Analyst Resume Examples & Samples

  • Support the development of CRO's LATAM, field and laboratory
  • Review curricula and final reports of waste, following GLP standards
  • Participation and support at all stages: planning, implementation, development and delivery of waste studies LATAM - OCS Residue Science LATAM
  • Perform alignment between areas of MKT, BA and BP to ensure that the data generated are aligned to Syngenta's strategy
  • Provide data through residue studies for area Regulatory Brazil
  • Support Risk Assessment team in setting MRL
  • Support the study monitors team in different types of projects / studies LATAM: waste studies for regulatory purpose, tolerance import and Pollen and Nectar
  • Ensure the delivery of data in accordance with the standards established by Product Safety
  • To promote the continuous development of CRO's LATAM
  • Assertiveness, organization, communication
  • 3 years of residue analysis experience, field trials
32

Manager, Device / Combination Product Safety Resume Examples & Samples

  • Directs, influences, implements and communicates complaint case processing and reporting policy and direction for Global device / combination product
  • Responsibilities may include writing position papers, literature review and analysis of safety data
  • Excellent analytical skills to perform safety data analysis and author rationale for reportability decision making
  • Experience providing clinical / medical input for Design History files
  • Evaluates new regulations and guidelines for potential process gaps; defines and implements specific policies and strategies to ensure compliance with regulations and close any identified potential process gaps
  • Communicates and coordinates across functional and global boundaries to ensure timely completion of device reportable events for global regulatory submission
  • Identifies, evaluates, develops and implements Global product safety policies, processes and system improvements, including quality plans
  • Bridges the knowledge gap between drug safety and device combination product safety
  • Identifies and anticipates potential department problems impacting ability to meet regulatory requirements and business goals; develops and implements methods of improvement and resolution
  • Manages the audit process, prepares responses, and develops associated improvement plans (e.g. FDA meetings; responses to warning letters)
  • Works cross-divisionally to influence business processes which impact product safety
  • Function as safety reporting subject matter expert for device and combination product within Pharmacovigilance
  • Ensures a positive employee relationship environment focused on providing opportunities for individual growth and strengthening Global Pharmacovigilance for succession
  • Manages and develops individual and team performance across therapeutic areas
  • Negotiates with cross-divisional counterparts on projects having significant financial, legal or regulatory simplification for therapeutic area
  • Ensures area maintains thorough knowledge of product(s) data, literature, labeling, key product issues and current records of required product information for devices and combination products as needed
33

Product Safety Manager Resume Examples & Samples

  • Define, maintain and supervise the safety process in the responsible region according to BT directives and relevant norms and standards (e.g. EN 50126, EN50128, EN 50129, SIRF, CSM, TSIs, etc.)
  • Support, review and contribute to safety cases, especially review of technical safety reports
  • Support the safety assessment in bids
  • Define, maintain and supervise the incident reporting process, ensure correct information flow in case of product safety-related incidents
  • Define safety requirements according to valid standards and directives
  • Act as single point of contact for safety engineering for product safety issues in case of incidents and accidents, report to product safety executive in such matters
  • Responsible for reporting system and governance of safety incidents
  • Assess the progress of international standardization groups whenever product safety is affected
  • Represent BT in standardization committees
  • Perform safety audits
  • Ensure the exchange of knowledge and best practices between projects and relevant organizational units
  • Master Degree in Engineering or equivalent
  • Min. 7 – 10 years of relevant working experience
  • Excellent knowledge of European and worldwide safety assurance and authorization processes, including relevant standards
  • Project Management and Quality Management experience (ISO 9001)
  • Proven problem-solving skills in complex technical environments
  • Strategic and analytical thinking
34

Product Safety & Raw Material Coordinator Resume Examples & Samples

  • Managing completeness and quality of product safety data for raw materials
  • Collecting raw material data relevant for accurate function of substance
  • Responsible for bridging additional data maintenance requirements on raw materials as detailed by further blueprinting efforts linked to substance volume tracking
  • Coordinating additional resources operating in other geographical areas collecting relevant data
  • Responsible for internal training of staff on raw material data maintenance process
  • Responsible for maintaining an up to data internal network within AkzoNobel Specialty Chemicals and stay updated of supplier developments
  • In cooperation with manager responsible for the complete and up to data repository of supplier safety data sheets accessible via the web interface application
  • Bachelor degree in chemistry or life sciences
  • At least one year relevant work experience
  • Fluent in Swedish and English (both written and spoken, additional language is considered a merit)
  • Knowledge and understanding of processes and systems
  • You have the ability to plan and execute own work efficiently while keeping stakeholders informed
35

Product Safety Senior Manager Resume Examples & Samples

  • Bachelor’s degree in Engineering, Chemistry, Biology, Toxicology, Product Safety, Regulatory Affairs, Public Health or closely related field, technical engineering or science discipline
  • 10+ years of product development experience
  • 5+ years in managing a team of product safety and regulatory personal
  • 2+ years directly managing international staff
  • Demonstrates ability to build partnerships across and between functional groups
  • Demonstrates ability to express safety and compliance matters in terms of business language and business impact
  • Demonstrates expertise in leading testing protocol development and execution
  • Demonstrates a proven track record of successfully leading product safety and regulatory compliance systems while partnering with global suppliers
  • Demonstrates strong working knowledge of product safety and regulatory compliance systems and industry regulations
  • Demonstrates experience working closely with third party test labs to resolve challenges, strengthen standards, interpretation, and application
  • Demonstrates exceptional understanding of cost of failure financials and experience managing cost of failure reduction projects
  • Demonstrates effective planning/organizational skills with a demonstrated ability to multi-task and set priorities
  • Demonstrates evidence of taking initiative and/or leading projects
  • Demonstrates strong project management skills
  • Demonstrates strong problem solving skills with evidence of systematic approach for identifying problems, root-cause analysis, and implementing the “fix”
  • Demonstrates ability to work independently or perform in a team environment
  • Demonstrates proficient computer skills (Excel, Word, Outlook, Project, PowerPoint
  • Demonstrates excellent communication, interpersonal, writing, planning, and presentation skills and ability to lead by direct control and influence for positive business outcomes
  • Demonstrated experience working with Asian suppliers/partners on Product Safety and new product development is required
  • Master’s degree in one of aforementioned disciplines
  • Consumer Products Industry Experience
  • Manufacturing experience in countries outside of the U.S
  • Demonstrates specific knowledge in the chemicals, plastics, metals, wood, or electric commodities
36

Dutch Speaking Product Safety Expert Resume Examples & Samples

  • Monitoring and reporting national chemical and trade control legislation for Benelux
  • Ensure compliance with legal chemical reporting regarding marketing of our products for the Benelux countries
  • Handle customer enquiries
  • You have a chemical background at master level (e.g. Master of Science or similar technical education)
  • 2-3 years of experience from a similar position or within the chemistry area is an advantage but not a prerequisite
  • As a person you are analytical, systematic, and able to work under minimum supervision
  • You are good at prioritizing your tasks and you have strong interpersonal skills
  • Fluency in Dutch is required as well as advanced proficiency in French and English
  • You are confident with MS Office and databases
37

Senior Product Safety Specialist Resume Examples & Samples

  • Preparing and maintaining commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for each Business Unit (BU) and otherwise ensure ongoing compliance with international, federal, state, local, and corporate product safety requirements for such BU products
  • Counseling and advising each BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products
  • Proposing solutions to solve product safety regulatory issues in a sustainable, sound, safe and cost-effective manner
  • Maintaining a thorough knowledge of emerging technical and regulatory issues pertaining to each BU and its products
  • Supporting Manager, Product Safety & Regulatory Affairs in efforts to effectively advocate the Company’s product safety and product stewardship positions with trade associations, government agencies and non-governmental organizations
  • Providing timely and appropriately responses to product safety and regulatory affairs inquiries from customers, users, and agencies, and others regarding the BU products
  • As directed, conducting training for BU research and development, commercial and manufacturing personnel, and customers on product safety and regulatory affairs issues related to the BU products
  • B.S. Degree in relevant field of study (e.g. environmental science, biology, chemical engineering, chemistry, toxicology) or equivalent and 5 years experience in a product safety/regulatory affairs or related area
  • A knowledge of relevant federal and state laws and regulations governing product safety such as TSCA, FIFRA, FDA, OSHA Hazard Communications, hazardous materials transportation as well as knowledge of product risk management and product stewardship is essential
  • Strong interpersonal and written and oral communication skills, and must be capable of interacting with diverse groups at all technical levels such as customer service, plant personnel, R&D, customers, technical consultants, contractors, etc
  • Demonstrated ability to work independently as well as a part of a diverse team
  • Effective written and verbal communicator, in both one-to-one and group discussions
  • Current proficiency in standard office software (i.e., word processing, spreadsheet, database, and presentation packages), as well as, the ability to learn specialized applications such as SAP and ARIEL required
38

Product Safety Support Associate Resume Examples & Samples

  • Process enhancements/improvements; SOP development
  • Toxicology experience
  • Chemical management experience
  • Minimum B.S. or M.S. Chemistry, Natural, Environmental or Life Sciences
  • Demonstrated communication and interpersonal skills in a collaborative team environment
  • Demonstrated precision and accuracy when managing information and strong organizational skills
  • Ability to work independently while managing and successfully completing multiple projects/tasks in a timely manner
  • Regulatory, environmental, toxicology or chemistry experience in a highly regulated industry
  • 1-2 years consumer products experience or 1-3 years of related experience
39

Manager, Product Safety & Regulations Resume Examples & Samples

  • Ensure that the requirements of chemical and product safety legislation for BASF products are fulfilled in Greater China
  • Develop and implement compliance strategies for Performance Material (PM) Greater China. Steer cross regional, functional and countries so as to establish processes and tools to ensure compliance
  • Act as product stewardship representative of the BU. Attend regular BU industry meeting and provide product stewardship / safety and regulations training to sales colleagues
  • Lead product stewardship for PM in Greater China
  • Lead functional report to deliver professional PS&R services to internal business partner and external customers, including but not limited to maintain CAMDS database of relevant BU portfolio
  • Lead the related registration or certification i.e Bluesign, new medical device or new substance for drinking water with the government authority
  • Orchestra advocacy. Represent BASF at industry associations and interaction with authorities on topics including but not limited to applications of automotive, electrical and electronic appliances, food contact, drinking water contact, toy, medical device, fire safety, textile, apparel and footwear. Strategize on our advocacy direction in the cross segment field
  • Identify and communicate chemical legal requirements that may affect PM operations in Greater China
  • Provide guidance and consultancy advice on all issues related to China regulations regionally and globally
  • Support plant audit on Good Manufacturing Practice (GMP) for plastics
  • Support new initiatives and special projects in the area of product safety and regulations for PM China as required
40

Senior Product Safety Engineer Resume Examples & Samples

  • Leads cross functional meetings with product development team(s) on emerging product safety issues to evaluate, trend, escalate; assists in root cause and corrective action(s)
  • Drives product safety concerns from identification to resolution, through corrective action and Phase 5 assessments for enterprise learning
  • Monitors and analyzes safety claims along with warranty claims, technical &/or consumer calls, service parts history and other data sources to accurately depict potential concerns
  • Regularly communicates product safety information throughout the organization
  • Regularly interacts with PSS Data Team, Safety Claims & Investigations, Field Service, Design Engineering, Plant Quality, Supplier Quality, Regulatory and Legal teams
  • Evaluates product safety progress & recommends changes in procedures to meet corporate product safety & quality objectives
  • Minimum 5 years of experience in product development and/or product quality
  • Proficient with data analytics, trending and reporting
  • Extensive use of the Microsoft Office suite. Experienced with PPT & Excel
  • Strong communication, problem-solving & ability to influence required
41

Product Safety Manager Resume Examples & Samples

  • Leadership of the Physical Safety Team
  • Generate physical safety reviews to manage the risks inherent in the design and end-use of consumer products
  • Support product regulatory compliance
  • Development of internal processes and procedures
  • Experience as a team leader
  • Experience in drafting electrical device test plans, performing electrical device testing, and managing electrical device certification
  • 4 year university degree/advanced degree (highly preferred) and 5-7 years of relevant experience
  • Highly advanced technical aptitude – Knowledge in key business areas of product physical safety with a thorough understanding of principles and test methodologies
  • Problem solver and forward thinker – Ability to analyze, disaggregate information in a structured way, identify core issues, and synthesize options moving forward to resolution. Also, the ability to predict future issues and concerns
  • Strong communication – Ability to communicate technical information effectively within all levels of the organization
  • Strong multi-tasking skills – Ability to balance and prioritize workload for a portfolio of projects
  • Strong mentorship – Ability to educate and assist less experienced staff
  • Strategic leadership – Ability to apply technical expertise to benefit the larger organization
  • Licenses – Professional Engineer or other appropriate licenses and certifications
42

Senior Product Safety Specialist Resume Examples & Samples

  • 5 – 10 years of product development experience
  • Demonstrates expertise in development of new specifications, protocols, processes, procedures, and policies
  • Demonstrates expertise in execution of product safety management programs/systems
  • Demonstrates a proven track record of successfully leading compliance systems while partnering with suppliers
  • Demonstrates strong working knowledge of compliance systems and industry regulations
  • Demonstrates experience in working closely with third party test labs to resolve challenges, strengthen standards, interpretation, and application
  • Demonstrates good understanding of cost of failure financials and experience in managing cost of failure reduction projects
  • Demonstrates competence with Hazard Communication Regulations (e.g., FHSA, OSHA, and GHS regulations) , Chemical Restriction Regulations (e.g., CPSIA, REACh SVHC), Chemical Registration Regulations (e.g., TSCA, DSL, NICNAS), and Consumer Product Safety Regulations (e.g., NHTSA, CPSC, FDA)
43

Senior Manager Product Safety Resume Examples & Samples

  • You are the central contact person for all product safety matters; internally towards the mainly the Buying teams, Legal and the PR department and externally towards our suppliers, our testing partners, federal agencies and relevant NGOs
  • You are responsible for the process management and external stakeholder-management (in collaboration with the Buying and Legal department) in all cases where product safety is a risk, including executing callbacks
  • You are in charge of the continuous improvement of our safety standards by monitoring legal requirements and changes, relevant newsletters of NGOs, the industry or any other relevant sources to be aware of
  • You manage the testing procedures, executed by external laboratories
  • You support and educate our suppliers in terms of product safety, restricted substances, REACH and other valid requirements (e.g. recommendations by BFR, CADS, etc.)
  • You lead and develop a team of 4 people
  • You participate and drive internal projects to improve our safety-related processes
  • A corporate culture where your skills are judged only by your results - our motto: Every Day is a Casual Friday
  • Also a feel-good team: We don't just work well together, we also like to get together after work
  • Training and further development opportunities to expand your skills and help you on your way
  • The security of an expanding company with more than 11,000 employees and a company pension scheme
  • Everything your retail-loving heart could desire thanks to our attractive employee discounts in our online shop
44

Product Safety Associate Resume Examples & Samples

  • Comply with relevant regulations, policies and procedures on Pharmacovigilance
  • Record, report, and follow-up on adverse events and other Reports of Human Safety Information which have been received from various sources (e.g. clinical, named patient, spontaneous, literature, third party)
  • Ensure adverse event reports and other Reports of Human Safety Information for GSK Consumer Healthcare products are accurate and reported on-time to GSK Central Safety
  • Ensure that pharmacovigilance files for GSK Consumer Healthcare products are accurate and well maintained
  • Contribute to other case management activities and day-to-day activities for GSK Consumer Healthcare products
  • Compile reports to facilitate local signal detection (e.g. line listings, monthly graphs) Pharmacovigilance projects, process improvements, and quality initiatives which are aligned with the strategic direction of GSK Australia
45

Head of Quality & Product Safety Resume Examples & Samples

  • An international team of experts to inspire and support you
  • Exciting career paths tailored to your skills and development potentials
  • Attractive employee discounts in our online shop
  • An easily accessible workplace right on the main arteries of the hottest Berlin districts
46

EU Product Safety Analyst Resume Examples & Samples

  • Data-driven decision making or quantitative analysis skills (including knowledge of Excel and / or SQL)
  • Knowledge of consumer product safety regulations with background experience in product safety and/or regulatory compliance management with government agencies
  • Experience in deep diving and complex investigation handling and delivery of investigation summaries
  • Ability to understand, troubleshoot and describe complex technical processes and issues
  • Language proficiency in Polish, Turkish or Spanish an advantage
47

Senior Product Safety Manager Resume Examples & Samples

  • Support the Director Product Safety and Compliance (Global) in creation, distribution and execution of Product Safety policies, projects and programs
  • Observe legal developments related to chemical/mechanical safety of products and packaging applicable for adidas Group products and services
  • Closely liaise with the Legal Department, Operations, Quality/Technical Services/Product Creation Testing teams and Social & Environmental Affairs to support the development and updates of corporate policies and operating procedures related to product safety
  • Act as help desk for in-house departments in case of technical questions regarding the correct application of product safety standards
  • Support sourcing departments (technical services/quality/product creation testing) in establishing and maintaining systems for tracking supplier compliance with standards
  • Engage with the Legal Department and external parties to obtain actual information on legal developments related to product safety/conformity standards (e.g. safety in design, material composition, product marking, disclaimer and advertisement)
  • Closely track changes in regulations and special customer requests
  • Support quality/technical services/product creation testing departments in developing and issuing corporate policies and standard operating procedures
  • Develop technical briefings and training measures to product creation departments, licensees, technical services and quality departments regarding safety requirements
  • Provide help desk services for US Group entities developing products
  • Support the development, maintenance and application of monitoring procedures to assess business entities’ compliance with product safety standards and related Group policies
  • Establish and maintain a library of safety regulations relevant and applicable for adidas-Group operations
  • Maintain and run the CPSIA Consumer Data Base according to the rules specified by the US CPSC and serve a respective main contact
  • Maintain and support the A01/CPSC data base to provide the Product Safety Management with product specific data on safety and conformity
  • In coordination with the legal department and SEA represent the company as technical expert at external US technical associations/committees (in particular ASTM) dealing with product safety, standardizations and norms
  • Strong background in technical sciences e.g. product engineering/material science
  • Mature knowledge in applicable product safety standards and norms, testing procedures
  • 5 years of work experiences in product safety/conformity area for an international company operating in the consumer goods industry
  • Strong background in product safety, consumer protection laws
  • Good understanding in product development, supply chain management processes
  • Very good communication skills (verbal, writing) in English, second language for LAM countries (Spanish/Portuguese) a plus
48

Avp-r&i Product Safety Resume Examples & Samples

  • To mentor and develop current product safety teams. Total team is 14+ members
  • To work with senior management on issues related to safety in terms of company responses and positions on our products and safety protocols
  • Ensure the safety attestations and claims certificates are completed by the group to support launches and registrations
  • Must have a PhD in Toxicology or related discipline
  • Minimum of ten years industry experience with similar time contributing to the Product Safety field via participating in PCPC, SOT and other Product Safety professional associations,
  • Must have prior Team Leadership experience
  • Able to interact successfully within an R&I environment
49

Associate Director, Product Safety Resume Examples & Samples

  • BS/BA degree (or higher) in Nursing, Pharmacy or other Life Sciences with a minimum of 7 years relevant experience
  • In-depth knowledge of the Global safety environment, international regulations and guidance documents
  • Previous supervisory experience with demonstrated leadership skills
  • Ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Ability to influence or gain the acceptance of others
  • Experience managing projects with demonstrated organizational skills
  • Demonstrated ability to drive for results and meet deadlines
  • Strong knowledge of regulatory requirements applicable to adverse event reporting, clinical studies, study protocols and reports
50

Intern, Product Safety & Risk Management Resume Examples & Samples

  • Support initiatives including, enlightening pharmacy students with the various opportunities within the pharmaceutical industry for pharmacists. Educating on topics including pharmacovigilance, product information and risk management activities
  • Participate in the processing of adverse event by working with the PV Operations Team
  • Assist in the review of Periodic Adverse Drug Event Reports for submission to FDA within required timelines by collaborating with Safety Surveillance Team
  • Learn the aspects of pharmacovigilance agreements and compliance metrics by collaborating with the Governance and Compliance Team
  • The successful candidate will have preferably completed a minimum of their sophomore year and be currently enrolled in an accredited college or university in an accredited School of Pharmacy degree program, or a related field of study. A minimum 3.0 GPA is strongly preferred. Related experience and/or education may be considered
  • Must possess knowledge of industry regulations for the management of adverse drug experiences. This includes Mylan-specific procedures as well as proper documentation for the reporting of adverse events to the FDA
  • Must possess a professional presence, excellent written and verbal communications skills, excellent interpersonal skills, organizational skills, and computer skills, including Microsoft Word, Excel, Outlook, and PowerPoint
51

Director, Product Safety Resume Examples & Samples

  • Directs and/or performs investigations of Broan-NuTone and Broan-NuTone group products involved in claims, both in Hartford and elsewhere
  • Prepares summaries of product investigations, which are at once factual and strategic, using still photography, close-up still photography and video
  • Directs and participates in field/site investigation related to claims
  • Prepares summaries of field/site investigations, using still and sometimes video photography
  • Selects, engages and directs outside experts, strategically and financially, in activities related to product claims
  • Directs and coordinates the activities of representatives of the third party administrator selected by the company
  • Interviews and engages local defense counsel to represent the company, as required
  • Administers defense activities, coordinating with counsel, including guidance in strategy, schedule/timeliness, and costs
  • Testifies in depositions and in court as the company representative knowledgeable in the areas of product design, manufacture, testing, sales and distribution
  • When strategically appropriate, occasionally testifies in deposition and in court as an expert in product technology, including matters related to electrical, air movement, design, manufacturing, installation, National Electric Code, and product applications
  • Coordinates and participates in settlement activities when strategically appropriate, including the establishment of limits, and both obtaining and granting authorizations
  • Participates in alternate dispute resolution (ADR) activities where appropriate
  • Provides liability avoidance advice and training for the Broan-NuTone group
  • Provides occasional advice to and maintains contact with those Broan-NuTone personnel who administer the warranty program
  • Organizes, trains, and monitors the Product Performance preventative programs at Broan-NuTone and group companies to assure new designs, changes in designs or processes are closely reviewed from the critical potential of user misuse, abuse, reliability and/or quality issues, which could lead to liability questions, as well as consumer viewpoint
  • Participates in, or directs, certain research activities as appropriate, either independently or in conjunction with others
  • Writes, for publication and internal use, reports, policies, procedures, and guidelines as a means of accomplishing selected objectives
  • May participate in selected trade association, codes, standards, and government activities, which have the potential for significantly affecting the company
52

Senior Product Safety Specialist Resume Examples & Samples

  • Handle product quality complaint and adverse event reports, documenting each appropriately
  • Handle product information requests
  • Perform routine follow-up on adverse events and quality complaints
  • Entering case information and navigating PV Safety Database, including the advancing of cases within the workflow and understanding and conducting various medical coding applications
  • Act as a resource to Product Safety Specialists and participate in training of new Product Safety Specialists, as assigned
  • Develop and maintain knowledge of Mylan products and their potential adverse events
  • Provide after-hours coverage for urgent calls on a rotating basis
  • PharmD. or Bachelor of Science degree in Nursing or Pharmacy is required. Minimum of four years of experience. However, a combination of experience and/or education will be taken into consideration
  • Must possess a strong clinical and scientific background. Must be familiar with electronic safety databases, coding dictionaries and query development. Must possess knowledge of Mylan products and their potential adverse effects
  • Must possess strong and effective communication, skills, and time management skills. Must possess good drug information research skills and be able to conduct on-line research. Must possess computer skills by using Microsoft Outlook
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems. Ability to add, subtract, multiply and divide
  • Normal office situation. Typically sitting at a desk or table
  • Proficiency in speaking, comprehending, reading and writing English is preferred
53

Senior Product Safety Engineer Resume Examples & Samples

  • Bachelor’s degree in scientific discipline, preferred EE or Physics
  • Experience with European Union’s “Low Voltage Directive” and the EN61010-1 standard, as well as the U.S. (UL-61010-1) and Canada (CSA C22.2#61010-1) variants
  • Experience with safety assessment and evaluation of Test and Measurement products
  • Experience with safety reviews of prototype products, including reviews of schematics, drawings, and other technical documents
  • Experience participating in UL’s Data Acceptance Program and Canadian Standards Association’s Category program, and qualified for submitting test data under these programs
  • MS Office applications proficiency
  • Excellent Communications
54

Senior Product Safety Engineer Resume Examples & Samples

  • Five years of engineering experience in consumer, medical, military, space product design or reliability engineering experience with a deep knowledge of electronics design, safety, risk and failure analysis. Including expertise in
  • Driving product design for safety and compliance to IEC/EN/UL/CSA 60950, 62368, 62133, 2054, 60825, 62471 and 60065
  • Understanding applicable test equipment, test procedures, and agency requirementsfrom above Safety Standards
  • Interpreting and negotiate requirements, apply knowledge to new situations and confidence to implement new solutionsand understand that customer safety is the priority
  • Managing relationships with vendor safety groups and contractors to develop and qualify product designs
  • Conducting component level safety analysis of electrical circuits and modules
  • Conducting FMEA and Safety Fault Tree Analysis (desirable)
  • Conducting detailed failure analysis and developing lessons learned
  • Technical writing and data analytics
  • Someone who will be both, confident to work independently and be a good team member
55

Product Safety Data Specialist Resume Examples & Samples

  • Managing completeness and quality of physical, chemical and toxicological data and assessment for classification of substances and raw materials
  • Managing substance and raw material portfolios to ensure compliance for AkzoNobel Specialty Chemicals
  • Support the Business Unit in terms of documents and information
  • Responsible for maintaining expert knowledge of systems used (especially EH&S) in order to act as internal expert
  • Responsible for leading/participating in product safety related projects
  • Responsible for setting up harmonized processes within own area of responsibility in the Business Area concerning business processes and change management
  • M.Sc (or B.Sc) in chemistry or life sciences and/or corresponding relevant work experience
  • Excellent understanding of processes and systems
  • Proven ability to enhance data reliability (i.e. work accurately)
  • Good knowledge in classifications and labeling requirements globally
  • Experience working with SAP, especially EH&S module is considered a merit
  • LI-PH
56

Product Safety Manager Resume Examples & Samples

  • Bachelor’s Degree in Mechanical Engineering
  • Minimum of 8 years of experience in a manufacturing environment involving industrial/construction equipment or other heavy equipment
  • Master’s Degree or Professional Engineer License in related field
  • Background with industry standard development, regulatory compliance, and risk assessment
  • Experience in application of product safety principles to new product design and product support
  • Leadership experience in product design or manufacturing environment
  • Strong written communication skills including detailed content review and editing
  • Integrity and trust
  • Listening skills
  • Influencing skills; internal and external
  • Process management
  • High cultural competence and appreciation of the needs of different cultures and practices
57

Senior Manager Product Safety Resume Examples & Samples

  • Strong computer skills in Word, PowerPoint, Excel, etc. are essential
  • Strong strategic thinking to envision and build team
  • 25% domestic and international travel required
58

Product Safety Senior Associate Resume Examples & Samples

  • Analyze and label accordingly the customer reviews that notify us about unsafe products
  • Analyze and identify the recall notifications from the dedicated websites
  • Identify the ASINs live on the Amazon websites for which there is a recall notification
  • Identifying improvement opportunities
  • Training and mentoring other Associates
  • Analyzing quality and process issues and recommending corrective actions
  • Flagging any updates received from stakeholders on process to Lead/Manager
  • Taking part in stakeholder calls, leading and documenting the discussion
  • Quality/Metric Oriented
  • Ability to analyze and identify patterns in large data sets
  • Decision making aptitudes based on given guidelines and in ambiguous contexts
  • Must be comfortable working with large data sets
  • Good knowledge and experience in internet navigation and research – finding specific information about products in a timely manner
  • Ability to multitask
  • Problem solving abilities
  • Excel/Office package basics (basic formulas knowledge)
  • Excellent verbal, reading and listening English comprehension skills
  • QA / Compliance and Customer Orientation background preferable
  • 2 years overall job experience
  • Detail Oriented
  • 1 - 2 years of experience in data-driven business operations processes – Business Process Outsourcing, Operations processes; Database management is considered advantage
  • Knowledge of consumer product compliance processes and regulations
  • Experience in product safety and/or regulatory compliance with government agencies
59

Product Safety Field Return Technician Resume Examples & Samples

  • 3+ years of evaluating the field performance of consumer products
  • Knowledge of Apple products and experience taking them apart, particularly iOS devices
  • A natural leader driven to provide consistent and accurate results
  • Someone who can both, be confident to work independently and be a good team member
  • Knowledge of hand tools and electronic measurement equipment including digital multimeter and high-speed video. Knowledge of sensors such as thermocouples is a plus
  • Problem solving ability utilizing creative and innovative thinking
60

Product Safety Engineer Leader Resume Examples & Samples

  • Product development experience: successfully launched a new product into a regulated market
  • Requires knowledge of
  • Product Safety Laws and Consensus Standards
  • Product Liability, Warranties, Litigation, and Insurance
  • Root cause investigation
  • Good technical leadership, planning and organization /control skills
  • Incident reporting and recall experience
  • Standards knowledge for products developed
  • Ability to plan and deliver effective training
  • The ability to communicate complex ideas succinctly and persuasively to peers, management and customers
  • Ability to work effectively within a team orientated environment
  • Ability to work in and guide multidisciplinary teams
  • Demonstrated ability to challenge the status quo using data and facts
  • Ability to drive a culture of safety
  • Strongly oriented towards prevention
  • Critical and independent thinker
  • Highly ethical
  • Bachelor’s or Master’s Degree in Engineering or Physics; 10+ years of progressive safety/compliance/quality experience in product development/sustaining engineering for a manufacturing company in a regulated industry preferred
  • Extensive experience with Government rule/regulation interpretation and reporting
  • Experience in product design/development desired
  • Experience with safety related product recalls
  • Self-starter with the ability to work independently or as part of a team in a fast paced environment
  • Strong communication (verbal and written), organizational and data analysis skills with the ability to work within diverse multidisciplinary teams
  • Ability to handle multiple tasks simultaneously and ability to manage project timelines
  • Ability to use state of the art techniques to perform early assessment and prediction of reliability, safety and quality levels of designs in systems with critical functional applications
  • Ability to identify problems, suggest viable solutions and make decision within the scope of responsibility
61

Senior Product Safety Resume Examples & Samples

  • Bachelor/Masters degree in Electronics/Electrical Engineering
  • Strong background in digital/analog electronics, power supply, telecom circuit design
  • In depth knowledge of worldwide product safety/EMC/telecom regulatory requirement
  • Project management skill desirable
62

Director, Global Product Safety Resume Examples & Samples

  • BS in Chemistry, Toxicology, Biology or related science; graduate degree preferred
  • Basic understanding of chemicals and chemical products, intermediate process streams, feedstocks, product specifications and production processes
  • An ability to communicate effectively with multiple stakeholders in product advocacy and product defense settings
  • Knowledge of environmental and animal toxicology testing protocols, data interpretation and associated product safety regulations under EPA, FIFRA, PMRA, ECHA, and OSHA
  • Knowledge of REACH a plus
  • At least 10 years of experience; > 15 years preferred
  • Approximately 30% travel is required; some international travel
63

Product Safety Manager Resume Examples & Samples

  • Develop business solutions which ensure compliance with consumer product regulations within the region
  • Establish programs and processes to investigate unsafe products while leveraging technology to improve efficiency and scalability
  • Communicate and partner with stakeholders across organizations to define strategy, requirements, and timelines for major product safety initiatives
  • Manage multiple, high-visibility projects simultaneously, including communication to stakeholders and executive leadership
  • Bachelor’s Degree required and 4+ years of relevant experience
  • Intermediate to advanced level Excel, Word and other common desktop software applications; must also be comfortable learning proprietary web applications and software
  • Demonstrated ability to work well with individuals at all levels including technical/non-technical stakeholders to achieve critical deadlines
64

North American Product Safety Manager Resume Examples & Samples

  • This position works North American Safety Regulatory Compliance Manager as co-leaders of the NASI Safety Group and together they develop, update and enforce the Product Safety Escalation Process to Distributors, NAQA, SIA QE and Subaru Corp. QA
  • Monitor both distributor's field information, NHTSA and DOT information to quickly identify and isolate potential Subaru "safety" issues and prepare a Product Safety Alert. The Product Safety Alert indicates to NAQA, distributors and Subaru Corp QA that the investigation of the issue is Top Priority
  • Convene discussions with NAQA, both Distributors, SIA QE, to set the parameters of the investigations. Ensure that all groups understand and are meeting their assigned responsibilities. Both distributors must investigate their respective markets
  • The Safety Regulatory Compliance Manager proactively supports the action by providing safety notices and recalls of all OE's for similar incidences as well as any and all relative regulations
  • Notify Subaru Corp. QA and request any relative information from all other markets
  • Meet face to face with NASI President and NAQA Directors and other staff to present the investigation results, and ensure that the Safety Group has all pertinent data to present the case to the CSO
  • Coordinate and participate in negotiations and discussions between FUSA and NHTSA/DOT to promote their recognition for Subaru's proactive safety activities
  • As soon as a Safety Incident has been confirmed according to the parameters of the
  • Product Safety Escalation Process and in conjunction with the Safety Regulatory Compliance Manager, prepare the Product Safety Action Alert and present to Distributor Top Management and Subaru Corp. CSO
  • Once field action is determined, work with the Recall Committee, to ensure that the action is prompt and adequate to satisfy customer needs and Compliance with regulations
  • As necessary, attend field investigations with NAQA NJ and NAQA-IN to gather first hand knowledge of the actual situation
  • Attend “Safety Committee” meetings to explain the issues and the background of the investigation, related issues from other OE’s, and other relevant information to support the findings
  • Continuously monitor new safety regulations to understand the implications of such regulations. With the NASRC Manager, update process and parameters and educate to the related groups
  • Serve as coordinator for Stop Sale/ Stop Ship activities between FHI/SIA and Distributors and be responsible the quick notification and compliance
  • Travel Up to 50 % - Overseas and Canada**
  • Must maintain strict confidentiality within FUSA QA and FHI QA
  • Strong skills with MS Office, Oracle, MS Access, etc
  • Technical skills and knowledge of Subaru product, vehicle design and manufacturing
  • Strong knowledge of NHTSA/DOT and other Safety regulations and Canadian regulations
  • Strong interpersonal skills, able to coordinate and negotiate across several groups and cultures
  • Japanese language skill is a plus, but, if not, incumbent should be willing to learn Japanese
65

Product Safety Engineer / Manager Resume Examples & Samples

  • Experience supporting litigation, accident investigation, or expert testimony
  • Experience operating in a global multi-national company and interfacing with global agencies
  • Ability to work at heights
  • Open and fair-mindedness
  • Strong quantitative and analytical capability
66

Product Safety / EMC Engineer Resume Examples & Samples

  • Product Safety / EMC Compliance Engineer leadership position will support project work for Teradyne North Reading/Agoura Hills and sister sites of Eagle in Buffalo Grove, IL as well as Nextest and LitePoint facilities in San Jose, CA
  • Support and assist Development & System Engineer(s) to drive overall product safety accountability within and across engineering teams using RPD product design methodology. Represent Teradyne at various forums like TC66 or SEMI standards
  • Interface with certification suppliers, competent bodies, & test labs as needed and drive all product safety/EMC testing requirements. Insure compliance to all appropriate safety regulations and standards. Integrate into engineering teams at all Teradyne sites. Develop relationships with technical leads and engineering managers across sites and platforms. (International travel may be required.)
  • Conduct product safety analysis from circuit level schematics/wiring diagrams to system level Test Equipment. Draw conclusions from analysis and make formal component to sub-assembly level safety recommendations to engineering teams
  • Ensure continuing compliance on projects assigned by maintaining Test Reports and Constructional Data Forms (CDF) and by performing/contracting in house testing to support safety / EMC affecting design changes
  • Ability to support and maintain Teradyne Product EMC Certification to current requirements by performing EMC testing and revising and maintaining Technical Construction Files (TCF)
  • Education: BS required, BSEE/BSME or equivalent – MSEE/MSME+ preferred
  • Experience: 5 years plus working with engineers on designing for Product Safety compliance plus ability to direct lab technician in support of achieving product safety and EMC compliance requirements
  • Results oriented and proven ability to work with all engineering disciplines and marketing/sales to drive Product Safety needs to closure. Basic understanding of ESD and EMC performance at the sub-assembly and system level a plus
  • Needs to possess outstanding English communication ability (written, verbal, & presentation), team skills, and show a history of driving & closing actions
  • Must have strong knowledge of Domestic and International Electrical Safety Standards/Regulations such as SEMI (S2), National Electrical Code(NFPA 70), and European Standards (EN61010, EN60204, EN61326)
  • Working knowledge of ATE (or highly integrated electrical equipment). Experience with automation safety for robotics and Cobots a plus
  • Must possess an ability to summarize actions and learnings into an output for updating recommended practices related to Product Safety compliance
  • Understanding of the role of an engineering support group and the accountability to drive issues and resolve problems
  • Strong basic computer and lab equipment skills to allow for generation and maintenance of safety / EMC testing procedures and safety / EMC reports using word and excel. Experience with thermal data collection programs a plus
  • Hands-on ability to perform Product Safety testing using HiPot, Ground Continuity, leakage current and thermocouple equipment. Hands on capability to perform radiated / conductive emissions knowledge a plus
  • Working knowledge of Cadence Allegro & Mentor Pads file readers to support printed circuit board Safety/EMC layout reviews
67

Product Safety Expert Resume Examples & Samples

  • Proactively monitor internal and external data sources to identify, investigate and action potentially unsafe products before our customers are harmed
  • Provide automated and scalable solutions that will result in duty savings and ultimately benefit the program
  • Serve as designated specialist within the Product Safety area, acting as a point of contact and process expert for other colleagues
  • Coordinate and implement all areas of the Product Safety Program in collaboration with the Program Team
  • Work with Amazon’s Product Safety team to execute strategy, seek automation opportunities and leverage technologies
  • Communicate professionally with internal and external partners (operations, technical and program teams) throughout the Product Safety process
  • Partner with key stakeholders to define, identify and influence the development of new initiatives within the Product Safety Program
  • Create best practices by putting forth improvement ideas
  • Work with Amazon’s internal technology teams to support the development of creative and best-in-class product safety business processes that can scale up
  • Leverage data to continuously improve Product Safety at Amazon
  • 1+ years of experience in product safety and/or regulatory compliance fields
  • Strong written and oral communication skills in English
  • Intermediate written and oral communication skills in one of the following languages: French, German, Spanish, Italian
  • Good working knowledge of MS Office; MS Outlook, and MS Excel proficiency is an advantage
  • Indirectly coordinated and collaborate with other teams and internal and external stakeholders for at least 1 year
  • Overall work experience of at least 3 years
  • Degree in a relevant Product Safety and/or Regulatory Compliance field
  • Experience with Lean Six Sigma and other process improvement tools
  • Familiarity with SQL
68

Specialty Product Safety Resume Examples & Samples

  • Complete daily reconciliation activities by reviewing notes from previous day entered in source system, identify possible adverse events and/or product complaints, and communicate to applicable teams to ensure timely submission
  • Analyze data and create weekly, monthly, and quarterly reports to be sent to manufacturers for their reconciliation processes and internal invoicing department based on contractual requirements
  • Perform complete quality reviews of all adverse drug and product complaint forms
  • Review for required data elements and content to adhere to manufacturer and/or FDA guidelines
  • Communicate with pharmacy and nursing personnel for corrections or clarifications
  • Communicate with manufacturers regarding inquiries of submitted forms, missing forms or other day to day ADE inquires
  • Support manufacturer audits including gathering required data, SOPs, ADE training logs and other necessary materials
69

Associate Product Safety Specialist Resume Examples & Samples

  • Works with suppliers to obtain required toxicology and regulatory information, and conduct literature and toxicological database search to fill data gaps
  • Performs initial safety, toxicological and regulatory reviews of raw materials, and fragrances for YCC products
  • Prepare ingredient dossiers per applicable regulations under supervision
  • Conduct fragrance and formula review and enter information in YCC system
  • Reviews and coordinates safety testing on products and formulas during the product development processes to support CLP classification and product safety assessment
  • Conducts global regulatory reviews, and prepares product information dossiers per safety regulations under supervision
  • Provides regulatory support for specific chemical regulations pertinent to the customer's product lines
  • Responds to inquiries pertaining to regulatory and product safety. Provides recommendations and assistance to the Director
  • Build close relationships with YCC suppliers and vendors, and timely communicate the safety and regulatory requirements for YCC products
  • Represents Product Safety and Regulatory Compliance on various projects with the company, especially as related to ingredient safety and product compliance
  • Reviews, summarizes, and presents critical issues to the Director of the Regulatory Department on regular basis. Maintains a complete record of activities and submitting accurate and detailed reports on a timely basis
  • Minimal Bachelor’s Degree in Science (Toxicology, Biology, Pharmacology, or relevant scientific disciplines)
  • At least 2-3 years’ of experience in consumer products and ingredients safety and evaluation and regulatory issue management
  • Experience with chemical, cosmetic and toxic substances (air care or fragrance experience) strongly desired
  • Demonstrated success in multiple project management / coordination
  • Self-motivated, working independently without daily supervision
  • Proficiency with software and databases in SDS generation and CLP label development is desired
  • Must be detail oriented with effective verbal and written communication skills
70

Product Safety Review Specialist Resume Examples & Samples

  • May perform triage of source documents for medical safety review content and assign medical device vigilance assessment for identified adverse events
  • Perform initial safety review of product malfunctions and peritonitis events with no malfunction or causality to determine seriousness, and reporter’s causality
  • Ensure that the correct suspect medical device was selected within the Global Safety Database
  • Write narratives summarizing all relevant medical information for individual case safety reports
  • Code medical terms using standardized medical dictionaries (such as MedDRA)
  • Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters in conjunction with local affiliates
  • Interact with other product surveillance functional areas to process adverse events efficiently and reliably
  • Collaborate with relevant counterparts in the regional and country Pharmacovigilance functions to facilitate the global exchange of safety information
  • Interface with other groups (e.g. Quality, Regulatory, IT, Legal, business units, etc)
  • Serve on departmental committees and projects as needed to perform this job successfully, an individual must be able to perform each essential duty satisfactorily