Quality Engineer / Senior Engineer Resume Samples
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Quality Engineer / Senior Engineer Resume Samples
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CQ
C Quigley
Charlene
Quigley
2782 Quitzon Viaduct
Philadelphia
PA
+1 (555) 631 3091
2782 Quitzon Viaduct
Philadelphia
PA
Phone
p
+1 (555) 631 3091
Experience
Experience
New York, NY
Quality Engineer Senior
New York, NY
Hodkiewicz, Beer and Upton
New York, NY
Quality Engineer Senior
- Manages the reward and recognition policy and platform. appearance reports, PSW, Quality alerts, process flow, work instructions)
- Facilitate resolution of proactive quality initiatives; continuous improvements, preventative actions, mistake-proofing, etc
- Define and manage all customer quality plans
- Support Supplier Quality in supplier issues and improvements (RI, NCM, MRB, etc.)
- Prepare and present metrics associated with quality trends and related improvements within the supply base
- Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness)
- Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc
San Francisco, CA
Senior IT Quality Engineer
San Francisco, CA
Sawayn Inc
San Francisco, CA
Senior IT Quality Engineer
- Analyze performance test results and work with teams to resolve any performance issues
- Automates in Sprint work as well as regression suite
- Comply with standards and strategies of the software development life cycle
- Comply with standards of the software development life cycle and follow strategies, plans and procedures within information Technology software
- Work with the automation lead and functional testers to design and implement a robust and comprehensive automation strategy
- Create and maintain test cases in Rally
- Assist business users in defining User Acceptance Testing, test cases and plans
present
Dallas, TX
Senior Mfg / Ops Quality Engineer
Dallas, TX
Aufderhar-Heller
present
Dallas, TX
Senior Mfg / Ops Quality Engineer
present
- Work with Site Validation team and Manufacturing and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits
- Provide ongoing support for QC testing and product release throughout the product life cycle
- Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
- Review and approve raw material and product release test data, ensuring data integrity and compliance with test procedures and release criteria
- Review and approve validation protocols and reports, ensuring quality and completeness of validation packages
- Assist with determination of root cause, impact, and resolution of problems impacting production
- Assist with documentation and resolution of deviances that occur during validation
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
University of California, Los Angeles
Bachelor’s Degree in Engineering
Skills
Skills
- Excellent knowledge of statistics (SPC)
- Excellent Knowledge of Storage Subsystem products, HDD, PCBA’s, PSU’s, Plastics and Sheet Metal
- Excellent knowledge of ISO9001:2008 and 14001 EMS
- Support management in the development and implementation of the company’s quality management system and continuous improvement programs
- Report on the manufacturing quality of your assigned area
- Know the company’s quality policy and understand your role in carrying it out
- Assist in Quality auditing of CM manufacturing process
- Ability to create, review and publish customer visible 8D’s
- Green or Black-belt certified
- Experience within the IT industry including server and storage in volume manufacturing
15 Quality Engineer / Senior Engineer resume templates
Read our complete resume writing guides
1
Quality Engineer Senior Resume Examples & Samples
- Evaluate prospective supplier Quality Systems and conduct Gap Analysis, where required
- Prepare and present metrics associated with quality trends and related improvements within the supply base
- Current ASQ CQA or CQE certification is highly desirable, as is an RAB auditor accreditation
- Familiarity with Quality Systems (e.g., AS9100, ISO 9001, etc.), Lean Manufacturing, Manufacturing Process Control, Six Sigma, and Root Cause Corrective Actions (RCCA)
2
Senior Optics Quality Engineer Resume Examples & Samples
- Review optical drawings, specifications, and manufacturing operation documents to understand and apply necessary inspections to be conducted and equipment required for inspection of products
- Support Material Review Board (MRB) functions and disposition of optical non-conformances as a member of the MRB team, including dimensional, performance, cosmetic, and workmanship issues
- Plans and implements research methodology for inspection to apply principles of optical theory to engineering projects
- Owns, manages, and maintains calibration procedures and optical inspection instructions
3
Senior.procurement Quality Engineer Resume Examples & Samples
- Schedule and conduct suppliers QMS audits to ensure that all Suppliers QMSs meet the Quality requirements of Leach International and its’ customers, in accordance with AS9100, ISO9001, Boeing D6-82479, Mil –I-45208A, MIL-STD-790, ANSI, or other applicable standards
- Conduct products and processes (in-puts/out-puts) audit on key suppliers
- Control and manage accurate records of all supplier related documentations, which includes but not limited to: Surveys, CARs, CANs, pertinent communications, A.S.L., Quality Program Provisions, SDRs
- Review Supplier History files, Receiving Inspection Product History Cards, MRRs, Scrap Reports and any other applicable records to determine the continued status of Approved Suppliers
- Issue, track and follow-up of Supplier Corrective Action Requests, (SCAR)
- Offer assistance/guidance to Suppliers to correct quality issues, develop and conduct suppliers training on Compliance, Process Control and Continuous Improvement initiative (FAIR IAW AS-9102, Capability Study, Gage R&R, Geometric Dimensioning and Tolerance, PPAP, PFMEA, Problem Solving etc.)
- Maintain excellent working rapport with the Leach International Purchasing Department and other internal departments and Suppliers
- Conduct periodic audits all Purchase Orders placed for materials or services used in the manufacture of deliverable products, to ensure the accuracy of each Purchase Order and the inclusion of all applicable QPPs and customer requirements
- Actively participate in the Supplier Material Review Board
- Actively participates in Lean and 6s initiatives
- A Bachelor’s Degree from a four-year college or university in Electrical, Mechanical Industrial Engineering or Quality Assurance discipline
- Minimum of five or more years of experience in an Aerospace industry or equivalent work-related experience in Supplier Quality Engineering field related to the manufacturing of Electro-Mechanical devices
- Solid background in Materials and Processes (Metallurgy, heat-treating, chemical processing, coating, welding, brazing, machining, NDT)
- Sound knowledge in GD&T and the ability to understand technical drawings and specifications
- Sound knowledge of Lean and Six-Sigma tools: Kaizen (VSM, Standard Work, TPI, SMED), Problem Solving, DMAIC, DFSS, DFM, PFMEA, APQP
- Sound knowledge in AS-9100, AS-9102, ISO-9001, NADCAP and the ability to audit to these standards
- Outstanding communication skills both written and oral; especially technical writing skills
- Ability to create and present project information to a group of internal/external customers periodically
- Experience in creating process metrics, interpret trends, and offer solutions for process improvement
- Must be able to travel domestically and internationally for field assignments up to 70% of the time
- Advance computer knowledge in Microsoft Office Suite applications such as; Word, Excel, Access, Power Point, Projects, Visio etc
- Must be highly organized, detail oriented and have the ability to multi-task projects and priorities and work in a fast pace schedule driven environment
- Certified Quality Engineer from the American Society of Quality desirable
- Sound knowledge of Syteline ERP System and Synergis Adept System
4
Senior Product Performance Quality Engineer Resume Examples & Samples
- Bachelor’s degree in Engineering with 4+ years of engineering or medical device experience OR Master’s degree in Engineering with 2+ years of experience
- Experience in medical device industry
- Hands-on experience with product quality problem solving
- High desire to work with product and find the root cause of performance problems
- Ability to take initiative, think creatively, prioritize in a fast moving environment, and work independently
- Proven communication, analytical and problem solving skills. Statistical thinking and understanding variation are a definite plus
- Ability to perform effectively within a team environment is a must
- Must be willing to undergo the three-vaccination Hepatitis B series, or sign a waiver declining the vaccinations
- Comfortable working hands-on with medical devices that have been removed from human bodies
- Experience with designed experiments, test method validation and equipment qualification
5
Senior Advaned Quality Engineer Resume Examples & Samples
- Collaboration in interdisciplinary and customer specific project teams to develop interior systems and components
- Organize and coordinate Initial Sampling with our customers (VDA 2, PPAP)
- Support the Advanced Quality Engineers in cases of functional questions
- Working experience in quality planning related activities, preferably in the automotive industry
- High willingness to travel within the European region
- Holistic work on complex tasks beyond the usual limitations of disciplines and responsibilities
- An international environment with people from 84 nations at our German sites alone
- An authentic and open corporate culture
- The proverbial team spirit of Johnson Controls
6
Quality Engineer, Senior Resume Examples & Samples
- Bachelor's degree in Computer Science, Engineering or equivalent experience
- Extensive experience in Software Testing or Development, preferably leading a test or tools team
- Knowledge of software development life cycle and development environments
- Demonstrated experience with expertise in one or more of technologies: TCL, Perl, C#
- Experience working with Oracle and SQLite databases
- Self-motived and superior problem solving skills to solve ambiguous problems under pressure
- Strong verbal and written technical communication skills. Must have good interpersonal skills
- Strong technical leadership is a must. Able to lead a team of SW engineers to define, design, debug and deploy a complete manufacturing test software solution into the factory for high volume production
7
Senior Water Quality Engineer Resume Examples & Samples
- Technical knowledge and familiarity with state and federal water quality laws and regulations
- Experience writing and issuing Water Quality permits including experience with the federal National Pollutant Discharge Elimination System (NPDES) permit program
- Experience in developing policies and procedures where there is little precedent
- Working knowledge of databases and database design
- Ability to produce high quality and accurate reports in a timely and accurate manner
- Ability to apply negotiation and conflict resolution skills
- Ability to operate a personal computer and utilize software (e.g. Word, Access, Excel) to carry out complex information management tracking to account and report essential elements of information regarding the state and federal water quality permitting programs to the Environmental Protection Agency, local governments, Tribes and to internal and external clients and stakeholders
- Ability to communicate complex technical issues to the public
- A cover letter describing how your experience, skills and abilities meet the required qualifications of this position
- A resume outlining your professional experience
8
Senior IT Quality Engineer Resume Examples & Samples
- Ensure that quality processes are carried out through all phases of the Software Development Lifecycle
- Work with the automation lead and functional testers to design and implement a robust and comprehensive automation strategy
- Execute the daily automation runs
- Maintain existing automated test cases
- Evaluate and track testing results to ensure system applications are free from defects
- Establish and maintain test cases and test data in ALM and / or Quality Center
- Verify system performance objectives
- Analyze performance test results and work with teams to resolve any performance issues
- Actively participate in planning, grooming, standup, and retrospective meetings
- Participate in production implementation verification and be accountable for validating system quality including defect resolution
- Communicate and own problems, changes and enhancements that may impact data, workflow and / or functionality within the software
- Bachelor’s Degree in Computer Science or Engineering or equivalent experience
- 5+ years of experience designing and implementing test strategies
- 1+ year of experience using automated testing tools such as Selenium or QuickTest Pro
- Healthcare Industry experience especially using HL7 or other messaging formats
- Experience performance testing transaction based solutions
- Experience automating performance tests
- Experience using ALM / Quality Center or an equivalent enterprise testing suite
- Experience working with an international team
- Experience working in an Agile environment (Scrum methodologies is a plus)
- Relational database experience
- Scripting experience utilizing Python, Ruby or VB Script
9
Senior Color & Image Quality Engineer Resume Examples & Samples
- Works with ISP and application team to study image quality and color reproduction from different color filter array, color spectrum
- Develops objective image quality and color metrics through subjective analysis, and predicts image quality from fundamental sensor parameters
- Works with Process Integration/Simulation to study new color filter material, and suggest experiments based on color and image quality simulation
- Acts as primary feedback source to various inter-disciplinary teams for color and image quality evaluation
- Develops evaluation environment, hardware, software for image quality and color performance
10
Senior Pharma Quality Engineer Resume Examples & Samples
- Bachelor’s degree in Chemistry, Life Sciences, Engineering, or Physical Sciences plus 4+ years of experience or Master’s degree in Chemistry, Life Sciences, Engineering, or Physical Sciences plus 2+ years of experience
- 4+ years experience in a regulated or technical industry
- 4+ year’s medical device, combination or pharmaceutical product experience
- Knowledge of Combination product regulations 21 CFR Part 4
- Knowledge of analytical laboratory processes (test method validations, equipment qualifications, test method transfer)
- Knowledge of one or more manufacturing processes such as contract manufacturing, finished device assembly, stamping/forming, injection molding, machining, extruding, coating, plating, foundry, etc
- Experience in multiple functional areas (Quality, Manufacturing, Risk, Reliability, Regulatory or Laboratory) is a plus
- Knowledge, understanding and implementation experience with medical device/combination product quality systems, manufacturing operations, supplier quality, and regulatory requirements
11
Senior Operations Quality Engineer Resume Examples & Samples
- Bachelor of Science degree in Engineering (Mechanical, Biomedical, or Materials preferred)
- 4+ years of related experience with a Bachelor's degree
- 2+ years of related experience with a Master's degree
- Knowledge of quality tools, risk analysis, statistics
- Knowledge of Quality System requirements, ISO and FDA requirements (preferred)
12
Senior Business Unit Quality Engineer Resume Examples & Samples
- Leads/Support Problem Solving activities across the Global Business Unit
- Apply quality system elements as necessary to continuously improve, and achieve the quality objectives (DOE’s, Poka-yokes, etc.)
- Apply the appropriate Problem Solving Technique(s) according to the level of complexity of the situation (Six Sigma, 8D, 8 Steps RCCM, etc.)
- Effectively facilitate communication with Global Business Unit customers to ensure proper issue resolution and excellence in customer satisfaction
- Analyze voice of customer data to help locations continuously improve product integrity and customer satisfaction
- Bachelor’s Degree in Engineering
- 5 or more years of experience in a Quality Manager or Quality Engineer role
- Supplier validation and Qualification experience
- Manufacturing environment experience is required
- Willingness to travel up to 50% of the time to other company sites and client specific locations
- Experienced in utilization of Excel and Minitab (or equivalent) for data manipulation and analysis
- Injection Mold experience a plus
- Lean Environment & Implementation experience a plus
- Automotive Quality Systems experience a plus
- Must be a hands-on self-starting team player with a solid working knowledge in the fundamentals of solid and fluid mechanics
- Must be detail oriented, have solid organizational skills and have strong written and oral communication skills
- Excellent Project Management Skills
13
Quality Engineer Senior Resume Examples & Samples
- Understanding of, and primary customer interface for all customer quality specifications and requirements
- Coach and mentor individuals and cross-functional teams in quality systems, tools and philosophies
- Facilitate all quality related activity associated with customer product introductions within PPAP, etc
- Approval of all product changes (ECOs, deviations, validations, etc.) to ensure customer requirements and expectations are met, and verification that changes are correctly implemented
- Monitor processes (through auditing, metrics, etc.) to ensure product health
- Support Supplier Quality in supplier issues and improvements (RI, NCM, MRB, etc.)
- Identify and document products specifications related to safety agency and regulatory requirements (UL, CE, FDA, FCC, etc) including functional, electrical, mechanical and labeling specifications as well as mentor and lead the project team on safety agency and regulatory items
- Lead the development of the Product Risk Management Plan and define the required content of the Risk Management File for each unique project
- Participate in Process Failure Modes and Effects Analysis
- Outstanding written and oral communication skills, including customer interface in a matrix organization
- A minimum of a Bachelor's Degree in Engineering/Scientific field or equivalent experience is required
- Experience of 3 years is required for this position
- Equivalent industry experience of 5 or more years is highly desireable
- Electronics or medical device experience preferred
- Experience with lean or six sigma methodologies
- Process or measurement system validation experience
14
Quality Engineer Senior Resume Examples & Samples
- A minimum of a Bachelor's Degree in Engineering/Scientific field is required
- Experience of 4 years is required for this position
- Equivalent industry experience of 4 or more years is highly desireable
- Electronics or medical device experience
15
Quality Engineer / Senior Engineer Resume Examples & Samples
- Responsible for manufacturing quality goals and objectives for the assigned area
- Manage ‘Stop-Ship’ and Quality ‘Alert’ situations at CM manufacturer site
- Understand product issues along with implications affecting both customers and internal manufacturing processes
- Responsible for all quality issues for assigned area
- Assist in defining, establishing, executing and monitoring process improvement activity within the CM manufacturing facility. This will include all aspects of the process, including incoming material, production, and field quality
- Maintain measurements, recommend actions to control and improve elements such as Production Line DPM, Parts per Million and ongoing reliability
- Support the Customer Quality and Technical support Engineers. Involves problem management and corrective action reports (QIR’s)
- Responsible for Manufacturing Quality for Change Management Impact Analysis System requirements (EC controls)
- Produce periodic Quality Report to Sr. Management
- To lead 8D problem solving with the integrate team
- Support management in the development and implementation of the company’s quality management system and continuous improvement programs
- Know the company’s quality policy and understand your role in carrying it out
- Report on the manufacturing quality of your assigned area
- Assist in Quality auditing of CM manufacturing process
- Excellent knowledge of ISO9001:2008 and 14001 EMS
- Excellent Knowledge of Storage Subsystem products, HDD, PCBA’s, PSU’s, Plastics and Sheet Metal
- Excellent knowledge of statistics (SPC)
- Green or Black-belt certified
- Ability to create, review and publish customer visible 8D’s
- Bachelor Degree qualified in Engineering
- Experience within the IT industry including server and storage in volume manufacturing
- 4 - 7 years’ experience
- 6 Sigma training a plus
16
Senior Hardware Quality Engineer Resume Examples & Samples
- B.S/B.A. in Engineering or similar related field
- 4+ years of previous experience in a quality position in a regulated environment with B.S./B.A
- Experience with complaint investigations in highly regulated environment
- 6+ years experience in Medical Device industry preferred
- A successful track record of cross organizational project collaboration
- Strong understanding of FDA regulations is highly preferred
- Direct or indirect Project management experience. PMP certification is preferred
- Experience working with cross-functional design/development teams
17
Senior Mfg / Ops Quality Engineer Resume Examples & Samples
- Serve as Quality representative on project teams for new product design transfers
- Review and approve validation protocols and reports; ensure compliance with established procedures and sound validation methodology
- Review and approve manufacturing operational activities, such as Device History Records (DHR), nonconformance, CAPA, RMA, and customer complaints
- Work with cross-functional teams to resolve operational quality issues
- Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary
- Ensure the quality systems meet customer, corporate, or internal requirements and any other related requirement within the Quality Management System
- Participate in management of corrective action program (customer complaints) to ensure timely follow-up, completion and documentation of corrective actions
- Manage customer complaints and work closely with cross function in issue investigation and ensure timely response of to corporate/ customer
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits
- Other such duties that may be determined by Supervisor
18
Senior Production Quality Engineer for Elastomer Modules Resume Examples & Samples
- Primary Management and coordination of quality assurance on Business Unit level in plant
- Defining of quality improvement programs and monitoring of product quality and reject rate. (Error analysis, Continual Improvement Process, tracking of corrections and improvement measures)
- Disciplinary and functional management of directly subordinated employees
- Lead customer audits for the Business Unit
- Claim Management for the Business Unit
- Plant specific topics will be specified by General Manager
- Requalification of products
- Carrying out layered audits in the plant
- Processing of customer portals
- Customer documentation
19
SDE Supervisor Quality Engineer Senior Resume Examples & Samples
- Supervise and lead APQP process
- Develop and deliver training in area of expertise
- Coordinate cross functional technical problem resolution at Supplier
- Recognized expert in a particular commodity and/or process
- Drive business process improvements
- Conduct reviews of engineering drawings and specifications with suppliers
- Oversees/Manages and leads a small team of direct reports
- Manages talent within team including conducting performance reviews
- Develop plans to achieve established objectives
- Bachelor’s degree in Industrial Engineering, Chemical, Mechanical, Electromechanical or equivalent
- Minimum 5 years work experience; automotive industry experience preferred
- Demonstrated competence in development and management of New Supplier
- Knowledge of quality standards and tools (AMEF, PPAP, APQP, SPC)
- Knowledge of statistical methods, blueprint reading, problem solving and continuous improvement tools
- Professional interpersonal verbal and written communication skills required
- Must have highly developed organizational skills including the ability to prioritize, handle multiple projects simultaneously, and meet deadlines
- Proficient with Microsoft office products — Outlook, Word, Excel, PowerPoint
- Knowledge of GD&T
- 3 plus years of supervisor experience
- Bilingual (Spanish / English)
20
Senior Line Quality Engineer Resume Examples & Samples
- Drive and achieve QM target / Q KPI scorecard (FAR concern, Zero Spill, MRB / 8D / actions implementation , TAT, rating)
- Support Quality Specialist / Manager for data request by CQE on all MRB / 8D related discussion & follow up on measures
- Prepare MRB Form / 8D, perform effective problem solving& risk assessment with Prod/PE team & implement effective Poka Yoke measures
- Perform 8D corrective action effectiveness in production line + review FMEA
- Improvement project involvement & support customer/ certification audit
- Support Quality Specialist / Manager in issue QMR, timely excursion containment request to hold affected lots for relevant disposition avoiding risk shipment to customers
- Support Quality Specialist / Manager on Quality reporting, send problematic units for Failure /Rel lab analysis
- Review & Update FAR / Quality spec + participate in NLoZD projects for quality improvement
21
Senior Mfg / Ops Quality Engineer Resume Examples & Samples
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
- Ensure product development and validation programs meet requirements of FDA and ISO
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
- Own and/or coordinate all SCARs
- Directly support projects/investigations associated with supplier quality
- Track and trend supplier performance and recommend appropriate actions
- Collaborate with the procurement, purchasing, and product design groups to assure compliance/quality of new vendors/materials
- Function as a liaison between global supplier quality and operations
22
Software Quality Engineer Senior / Orlando Resume Examples & Samples
- Ability to evaluate data to identify systemic issues and trends
- Support deployment of F-35 TS deliverables to global customer sites, ensuring successful customer acceptance at site
- Support F-35 TS production, test, and DCMA acceptance at source efforts in between deployments
23
Senior Server Quality Engineer Resume Examples & Samples
- 3+ years as Individual Contributor Engineer - Hands on experience in CI, Tools, Automation
- Experience with design and building tools and frameworks
- Strong knowledge with object-oriented programming languages (Java, C++) and as well as design skills
- Knowledge of core Linux fundamentals
- Scripting skills (Python, Bash, Ruby, etc.)
- Experience with leadership in driving projects from start to finish
- Experience with highly scalable, multi-threaded systems
- Industry experience in similar roles at large scale companies
- Able to give multiple examples of creativity and critical thinking on the job
24
Senior Image Quality Engineer Resume Examples & Samples
- Developing image quality tuning tools. These tools will be used internally and externally by our customers
- Developing tuning procedures and automation tools
- Developing ISP simulator environments
- Tools documentation
- Creating scripts and experiments to achieve the best objective and subjective image quality in digital cameras and display technologies
- Matlab experience: image processing tool box and GUI development
- Familiar with Java, JavaScript, C or C#
- Good mathematical background in areas such as linear algebra and statistical theory
- Familiarity with Image quality metrics
- Working experience within the field of Image Quality or within software tools development and with a basic understanding of imaging technology
- Familiar with image processing technics and concepts
- Basic understanding of a camera system: CMOS or CCD sensor, ISP and optics
- Familiar with 3A (Auto White Balance, Auto Focus, Auto Exposure)
- Knowledge of image processing algorithms
- Familiarity with Image quality testing software such as IMATEST
25
Senior Design Control Quality Engineer Resume Examples & Samples
- 40% Design Control Process, 30% Training and Team Support, 30% Quality Mentorship
- 1) Quality Advocacy and Design Control Process Management
- Education: degree in science, or in electrical, software or system engineering. Advanced degree preferred
- At least one area of deep technical expertise applicable to the manufacture of medical robotic systems. A minimum of 7 years of experience in one of these disciplines and a few years in a second discipline. Example areas of expertise
26
Quality Engineer Senior Resume Examples & Samples
- Understanding of and primary customer interface for all customer quality specifications and requirements
- Experience with digital electronics testing and troubleshooting
- Coach and mentor individuals and cross-functional teams in quality systems, tools, and philosophies
- Facilitate all quality-related activities associated with customer product introductions within APQP, etc
- A minimum of a Bachelor's degree in engineering or related field or equivalent experience is required. Experience of 5 years as an engineer is preferred for this position assuming education requirements are met
- Proficient working knowledge of quality systems and tools for applicable industry requirements (i.e. AS, Medical, etc.)
- Proficient working knowledge of manufacturing process standards (IPC, etc.)
- Proficient data analysis skills
- Self-management capabilities
27
Senior Device Quality Engineer Resume Examples & Samples
- Accountable IMP device quality and technical-quality subject matter expert for product development device teams. May serve as IMP Device Quality lead for smaller scope product development device teams
- Provide quality engineering expertise on design controls, test method validation and equipment / process development for IMP device/combination product manufacturing
- Drive continuous improvement in combination product and device-related quality systems and business processes * Support root cause analysis and discrepancy investigations including the implementation of corrective actions
- Provides technical device quality support for internal/external audits and vendor qualification. * Provide input on policies and procedures and act as a subject matter expert on applicable quality systems, standards or business processes (as required)
- Establish work priorities to meet project targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance, and technology
- Perform any other tasks as requested by Management to support quality oversight activities
28
Medical Device Senior Systems Quality Engineer Resume Examples & Samples
- Develops and maintains the Risk Management Files, which includes Hazards Analysis, Use FMEA, Design FMEA (software & hardware), and Process FMEA, for assigned product families
- Solves challenging technical problems, provides expertise in related specific field of knowledge and consults on complex issues and projects
- Works within cross-functional teams to lead investigation of customer product complaints
- Utilizes Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks
- Ensures timely closure of active complaints providing tracking and trending data
- Leads Global Post Market Surveillance analysis, trending, and reporting
- Formulates responses to Regulatory Agencies in regards to Health Agency Reporting and performs Health Hazard Evaluations as needed
- Partners with vendors to facilitate the completion of Supplier Corrective Actions and to build quality relationships
- Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert
- Conducts self in accordance with the expected Halyard behaviors
- Communicates business initiatives, project milestones, and/or quality concepts to business partners including manufacturing facilities
- Ensures that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position
- B.S. in Engineering, Science, or equivalent
- Minimum of 7 years of collective experience in product development, manufacturing and/or quality within a medical device environment
- Experience supporting Electro-Mechanical Devices and servicing preferred
- Strong understanding of statistical concepts preferred
- Experience in Agile methodologies preferred
29
Senior Nuclear Quality Engineer Resume Examples & Samples
- Operates at the highest standards of integrity with a strong nuclear safety culture
- 10 years’ minimum nuclear quality experience ideally including major nuclear projects, procurement, manufacturing and construction and commissioning phase
- Management skills in a quality environment
- Significant experience in ensuring compliance with National and International standards such as GS-R-3, ISO 9001, ISO18001, ISO14001, ISO17020, ISO 17025, ISO27001
- Security Cleared to at least SC level
- Coming from a specific engineering discipline, qualified to degree level
- Chartered Quality Institute Member
- Experience of UK regulatory requirements
- Experience of interacting with UK Regulators
- Post-graduate qualification in quality
- Language and inter-cultural skills - especially Chinese, French, Japanese
30
Senior Network Quality Engineer Resume Examples & Samples
- Be a major technical contributor to cloud based customer solution testing strategy, lab set up, case design and implementation. The cloud solution lab built on the latest Openstack technology with Cisco ACI data center infrastructure
- Technical Point of Contact to stakeholders on failure analysis related issues for your products
- Handle end-to-end issues relating to failure analysis technical findings, provide analysis on trends and recommendations
- Articulate key technical issues to internal stakeholders, sense issues early, identify impact and partner to drive resolution
- Provide guidance and technical training to internal and external engineers
31
Senior Mfg / Ops Quality Engineer Resume Examples & Samples
- Work with Site Validation team and Manufacturing and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits
- Review any new and existing processes against cGMP and ISO 13485 requirements for equipment, software, test method, and process validation and help determine when re-validation is required
- Ensure site/system validation program meets requirements of FDA (21 CFR Part 11 and 820), ISO (13485 and 14971), and IEC 62304
- Manage and/or assist with management of overall validation key metrics with the manufacturing site and report status/progress to Quality Site Head
- Support maintenance of validated state under Site Validation Master Plan and update Site Validation Master Plan as needed
- Participate in validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports
- Review and approve IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility
- Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical manner as needed
- Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports
- Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts
- Ensure proper compliance to documented procedures, work instructions, checklists, and templates for system and process validation
- Uphold expectations for quality performance, continuous improvement, quality systems, process controls, and infrastructure for critical sustaining parts and new products
- Collaborate with peers and stakeholders to identify opportunities for process improvement on manufacturing facilities, processes and equipment
- Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
- Assist with documentation of nonconformances and process deviations
- Ensure that testers are trained on Good Documentation Practices and procedures for protocol execution and deviation resolution
- Assist with documentation and resolution of deviances that occur during validation
- Assist with determination of root cause, impact, and resolution of problems impacting production
32
Senior Systems Quality Engineer Resume Examples & Samples
- Responsible for comprehensive performance, system and scalability testing involving multiple features in public and private cloud environments
- Develop and execute end-to-end customer-workflow based test-plans
- Participate in Security Assessments and Auditing
- Develop automation for tests
- Reproduce and troubleshoot issues seen in production environments
- Work closely with various VMware Engineering, Product Management, Site Reliability teams
- M.S. in Computer Science or related technical field, or B.S. with equivalent work experience
- 7+ years of experience in Customer focused Quality Engineering role in Virtualization, and Security
- L4 to L7 experience a solid plus
- Cloud deployment and testing experience on Amazon AWS, Google, Azure, vCloud Air a plus
- Virtualization experience - Installation/Configuration/Administration (ESX/KVM)
- 3+ years of Python or equivalent Object oriented programming hands-on experience
- Security Domain Expertise with vulnerability and threat management experience
- Understanding of cryptography principles is a huge plus
- Proficiency in using source code control systems, continuous build integration, test case management and reporting tools
- Passionate about quality, wants to make a difference
- Ability to work in an agile, fast paced environment
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Quality Engineer Senior Resume Examples & Samples
- Assesses quality performance (or cost-of-quality) using statistical and analytical methods. Devises and implements various complex methods and procedures for inspecting, testing, and evaluating the precision, reliability, and accuracy of products, processes, and production equipment
- Develops and establishes advanced quality systems and procedures, inspection plans, quality performance trends, statistical plans, cost estimates, and technical quality plans for proposals. Ensures that project and/or process control documentation is compliant with requirements and/or contract
- Assesses the cost of, and determines the responsibility for, products or materials that do not meet required standards and specifications by performing difficult statistical analyses. May establish statistical confidence by identifying sample size and acceptable error and determining levels of confidence
- Provides input on quality to product development teams; recommends product ability improvements by facilitating process reviews, addressing technical data packages, manufacturing methods, equipment, tooling and training
- Develops sampling plans and inspections by applying attribute, variable, and sequential sampling methods. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality data
- 6 years or more of Quality Engineer experience in Aerospace, 3+ of those years should be in Aerospace manufacturing
- Able to effectively assess and implement continuous improvement techniques to quality and manufacturing functions
- Ability to read, analyze, and interpret technical journals, policies and recommend changes to procedures
- AS9100 Certified Internal Auditor
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Senior Scalability & Quality Engineer Resume Examples & Samples
- Develop testing capabilities ranging from fault injection to customer workload automation or simulation
- Prioritize, design and develop new and improvements of test infrastructure for coverage, efficiency, productivity
- Integrate additional code quality tools such as Address and Thread Sanitizer into development workflows
- Primarily use Python for test and infrastructure development, troubleshoot and contribute in C++ and Java
- Try as hard as you can to break Impala
- Python/Java/C++ programming and software engineering skills. We take pride in our test software
- 8+ years of experience in Software Development and Test engineering
- Familiarity with RDBMS internals, Database concepts and SQL is a big plus
- Able to debug, troubleshoot and resolve complex technical issues
- Tremendous attention to details; Solid interpersonal skills conducive to a team environment
- Familiarity with large-scale distributed systems and/or data management systems
- Experience with Apache Hadoop and its related technologies is a plus
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Senior Device Quality Engineer Resume Examples & Samples
- Accountable IMP device quality and technical-quality subject matter expert for product development device
- Establish work priorities to meet project targets and timelines. Maintain current status on all required job
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory
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Senior Production Quality Engineer Resume Examples & Samples
- Coordinate with external organization on customer feedback relating to manufacturing site which includes KD factories’ quality concerns
- Handle all customer feedback and coordinate within internal organization to analyse root cause and solving the issue through QSP
- Coordinate internal/external campaign relating to the product
- Represent manufacturing organization to join with Regional/Global Quality Action Group (QAG) on matters relating Product Quality
- Summarize, report and lead the improvement of product quality KPI (Customer claim & Feedback)
- Interface with Product Auditor team to analyse and compare correlation between internal (Audit score) vs external (FF1), identify and close gaps
- Monitor the product quality and take proper action according to quality procedure (DSO, Co-Pilot Management)
- Lead and manage corrective and preventive action concerning customer claim/feedback according to quality procedure
- Coordinate for the quality issue with customer (TSM and KD factories) and feedback to concern function
- Coordinate with the quality supporter in main plant for the quality issue and requirement
- Analysis the customer satisfaction survey report from both CBU & KD operations and find out the proper way to improve
- Bachelor’s degree in Industrial or a related field
- In case of a lower level of education, need a minimum of 5 years work-experience on automotive field
- Good communication skill and strong leadership
- Able and flexible to travel upcountry and abroad
- Good human relationship and communication with strong analytical and leadership skills
37
Quality Engineer Senior Resume Examples & Samples
- Process control
- Tractors manufacturing Process
- Glide Path FPM calculation
- Waterfall Reliability charts
- Financial basic understanding
38
Senior Safety, Compliance & Quality Engineer Resume Examples & Samples
- Implementing the Company's Safety and Compliance system to ensure that the Company's services are maintained to the level of excellence required by the Accountable Manager's Safety and Compliance policy statement
- Performing safety investigations and analysing findings within a maintenance organisation
- Maintaining and co-ordinating a Quality system to ensure fulfilment of the requirements of the Ministry of Defence, Military Aviation Authority, EASA and ISO 9110 while simultaneously meeting all customer Compliance requirements
- Executing the Quality Assurance duties and responsibilities, as defined by the MRP Part 145 MOE to ensure the Company maintains its accreditation as required for its operations
- Monitoring compliance with, and adequacy of, all aspects of the company organisation Maintenance and Engineering operations to ensure safe operational practices and airworthiness of aircraft
- You will implement and monitor safety and quality standards including the championing of the Company safety culture philosophy internally and externally and promoting a proactive and positive safety-first culture
- Ensure development of robust company Safety and Compliance management systems that meet regulatory requirements
- Implement the company compliance and audit surveillance system, perform audits and coordinate with Company managers to analyse root causes of different audit findings, obtain and evaluate related corrective and preventive actions
- Assist with the interface to Aviation Authorities and Customers on Safety, Regulatory and Compliance matters
- Represent the Head of Safety Compliance and Quality when necessary and assist in managing the strategy and implementation of the MoE
- Aircraft Engineer Licence and / or Bachelor degree or equivalent in Engineering / aviation services / aviation technology
- Have held aviation safety and compliance roles
- Lead auditor courses and auditing experience
- Completion of appropriate training courses, including aircraft type courses, SMS, safety risk assessment, relevant regulatory training
- Significant experience in aircraft maintenance, safety and compliance assurance, involving aircraft base and line maintenance, engine and component repair workshop and design organisation domains, is essential
- Experience in developing, documenting and auditing Safety and Compliance management systems
- Knowledge and application of Aviation standards, rules and regulations in particular Part 145 and Part M as well as an appreciation of Part 21, within relevant maintenance organisations
- Management/ application of databases and related information technology skills
- A high level of written and spoken English, including fluency in communication using technical vocabulary. Ability to communicate in any other European languages would be beneficial
39
Senior Engineer, Quality Control, Decanter Resume Examples & Samples
- Inspection, calibration and maintenance of Electrical components/equipment’s at Receipt QA during Goods Receiving stage
- Ensure adequate test set up at RQA for electrical parts and at final testing area
- Support, Supervise, Train and upgrade the knowledge of Electrical Operators
- Update electrical instructions based on inputs from R & D / Customer specifications
- Trouble shooting of the electrical issues on shop floor and maintain
- Ensure corrective and preventive actions on defective components including product audit
- Maintain inspection and test records of electrical parts
- Implement Design Changes related to electrical parts at Supplier and on shop floor
- Make SOPs for electrical parts
- Coordinate with R & D-Core Automation Team for getting know-how of good practices for electrical testing
- Handle two Touch Automation system testing (PLC)
- Responsible for Testing of standard, non-standard electrical panels and machine Factory Acceptance Test
- Coordinate with Sales Company order handler for electrical requirements of Customer
- 2-4 years of experience in Electrical parts testing and inspection from engineering industries, Automotive organizations, etc
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Senior Systems / Software Quality Engineer Resume Examples & Samples
- Analyzing Program metrics (such as cost, schedule, productivity), and identifying issues and interpreting trends
- Leading improvement efforts for key Program metrics
- Leading Root Cause Analysis as well as Corrective and Preventative Action solutions
- Ensuring flow down of Raytheon and contract program requirements both internally and to suppliers and ensuring compliance with contract program, quality and organizational requirements
- Helping to onboard new employees to the section
- Interfacing with customers and DCMA to ensure compliance and resolution of any reported issues
- Reviewing practices, procedures and processes, and seeking avenues to improve efficiency and effectiveness while reducing risk to product quality
- American Society for Quality (ASQ) Certification
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Quality Engineer Senior Resume Examples & Samples
- Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria
- Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs
- Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc
- Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation
- Read and interpret technical drawings, procedures, and protocols
- Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness)
- Document investigation findings in analysis report on GCS2
- Become a trainer for the Software related with complaints handling process (GCS2), as required
- Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
- Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
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Senior Pharma Quality Engineer Resume Examples & Samples
- 4+ years experience in the medical device, pharmaceutical or comparable regulated industry
- 4+ years combined experience in Quality, Manufacturing, Continuous Improvement, Sourcing and/or Laboratory functions
- Work experience with the following: FDA Quality System Regulations, current Good Manufacturing or Laboratory Practices (cGMPs or GLPs), ISO 13485 and/or ISO 9001 standards
- Experience understanding proper documentation / quality requirements for a regulated environment
- Computer Skills (Microsoft Word, Excel, Project, PowerPoint)
- Expertise in analytical chemistry, microbiology or sterilization
- COS or FTQ experience
- Experience with LIMS systems such as TriLIMS, MAQS
- Well-developed interpersonal communication, decision-making and leadership skills. Able to work with internal and external customers
- Basic statistical knowledge and application
- While performing the duties of this job, the employee is regularly required to be independently mobile. Stand/Sit/Walk 8 hrs/day. Frequent bending/stooping, squatting and balance
- The employee is also required to interact with a computer for extended periods of time (effectively use a PC, keyboard and mouse), and communicate with peers and co-workers
43
Senior Mfg / Ops Quality Engineer Resume Examples & Samples
- Provide ongoing support for QC testing and product release throughout the product life cycle
- Work with QC group to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed
- Establish and/or improve processes for raw material and product release
- Review and approve QC work instructions and change orders
- Review and approve raw material and product release test data, ensuring data integrity and compliance with test procedures and release criteria
- Balance risk, regulatory impact and business needs to achieve efficient and effective solutions for QC process improvement
- Collaborate cross functionally to manage non-conformance reports, change orders, and deviations, ensuring evaluation is performed in a timely manner and is properly documented
- Work with manufacturing teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed
- Review and approve validation protocols and reports, ensuring quality and completeness of validation packages
- Identify gaps in GMP compliance. Develop and execute strategies to close gaps in an efficient and compliant manner to improve quality systems and manufacturing processes
- Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated
- Apply experience and knowledge of regulations and standards to manage risks and guide actions independently
- Become familiar with the applicable technology to participate in technical discussions and risk-based decision-making
- Trend, analyze, and report on quality data in order to improve product and process. Develop recommendations based on data analysis
- Other such duties that may be determined by Management
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Senior Safety, Compliance & Quality Engineer Resume Examples & Samples
- Lead and Execute the Quality Assurance / auditing duties and responsibilities, in accordance with UK MAA MRP Part 145 regulation
- Implement the Company safety management system, conduct investigations, perform root cause analysis and monitor implementation of corrective action
- Assist in competency assessment and evaluation of certifying staff to meet the needs of the business
- Assist with the interface to Aviation Authorities and Customers on Safety, Regulatory and Compliance matters, leading technical issues, problem solving and continuous improvement projects
- Knowledge and experience in aircraft maintenance, safety, regulatory compliance and quality assurance, involving aircraft base and line maintenance activities
- Knowledge and application of Aviation standards, rules and regulations, in particular AS9100, AS9110, Part 145 and Part M and an appreciation of Part 21 within relevant maintenance organisations
- Experience in auditing and / or the application of Safety Management Systems including investigations and root cause analysis, promoting a positive safety culture
- Have the ability to work across all operational and support functions and will be able to demonstrate the correct behaviours in terms of investigating, challenging and supporting the business units and interacting with associates at all levels in line with the company values
- A high level of written and spoken English, including fluency in communication using technical vocabulary
45
Quality Engineer, Senior Resume Examples & Samples
- US citizen or US permanent resident required due to government contracts
- Demonstrated self-starter & the ability to perform with minimal supervision
- High level of analytical ability to identify and evaluate appropriate courses of action for definition and resolution of complex problems
- Certified Green Belt or equivalent; Lean Expert or Black Belt preferred
- Experience with Automotive or Aerospace products preferred
- Experience using Six Sigma Plus tools preferred
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Quality Engineer Senior Resume Examples & Samples
- Collaborate
- Initiate positive change
- Drive for results
- Provide technical expertise
- Proven track record of professional leadership, continuing education and excellence. Demonstrated self-development through professional education and certification
- Ability to motivate teams and manage through influence.Ability to communicate orally with customers, suppliers is critical. Regular use of phone and email is essential
- Hearing and vision corrected within normal ranges is essential for normal conversations, receiving ordinary information, and preparing or inspecting documents
- Experience creating world class quality performance
- Lean Manufacturing implementation experience and proven results Certification in APQP skills preferable
- Proficient with MS Office tools
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Senior IT Quality Engineer Resume Examples & Samples
- Automates in Sprint work as well as regression suite
- Create and maintain test cases in Rally
- Ideal candidate will possess the know how to create governance and process around quality assurance practices
- Candidate will be able to communicate the process to both business and IT leadership
- Hands on experience with automation using LeanFT
- 2+ year experience with automated testing tools
- General understanding of .Net, Angular and JSON
- 2+ years background with distributed environments
- Experience in a regulated industry, either Banking / Finance or Pharmaceutical doing release practices
- Software Testing Certifications such as Software Test Professional (CSTP), Certified Software Test Engineer (CSTE)
- Experience with QTP is strongly preferred
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Senior Hardware Quality Engineer Resume Examples & Samples
- Process planning, inspection and test methodology as well as Non-Conforming Material Control, issue resolution and product acceptance
- 6+ years of experience in a Manufacturing Process/Production Floor Support role within one of the following disciplines Quality, Process, Engineering or Operations
- Good general knowledge of industry technical standards (such as J-STD 001, IPC610),
- J-STD 001 or IPC 610 Certification
- Advanced Quality Science tool experience, e.g., PFMEA, DFMEA
- ASQ, Six Sigma Black Belt and/or Lean Certification
- Experience with Manufacturing Process Documentation Generation
- High energy, self-starting team player
- Ability to build effective customer relationships through partnering and collaboration
- Proficiency in the Microsoft suite of products (i.e. Word, Excel, Power Point)
- Knowledge of MRP tools (e.g., SAP)
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Senior Operations Quality Engineer Resume Examples & Samples
- Disposition of non-conforming material requiring advanced process/technical knowledge
- Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line
- Identify, analyze, and manage risk through product life cycle with use of FMECA and other risk management tools
- Interpretation of ISO and FDA requirements for creation and implementation of Quality System improvements and updates
- Make timely decisions related to product and process quality; determine appropriate project plan when complete information is unavailable
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Quality Engineer, Senior Resume Examples & Samples
- Bachelors Degree in Electric, Mechatronic, Industrial Engineering or related career
- 80% Bilingual Spanish/English
- At least 3 yrs. experience as a Quality Engineer
- Excelent Communication Skills
- Computer Skills
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Senior Data Quality Engineer Resume Examples & Samples
- Experience working in a Data Warehouse environment (Teradata, MicroSrategy, Oracle, Microsoft SQL Server) highly
- Experience testing analytics and machine-learning systems
- Knowledge of how to use Machine Learning to continuously improve big data quality
- Familiarity with Scrum/Agile project management methodologies and SDLC stages
- Experience building test automation tools and frameworks
- Proven experience with growing data quality engineers
- Prior healthcare or medical data testing experience is a plus
