QA Leader Resume Samples
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QA Leader Resume Samples
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MW
M Witting
Marcia
Witting
584 Hansen Station
Boston
MA
+1 (555) 498 5491
584 Hansen Station
Boston
MA
Phone
p
+1 (555) 498 5491
Experience
Experience
Los Angeles, CA
QA Leader
Los Angeles, CA
Pfannerstill Group
Los Angeles, CA
QA Leader
- Software Quality or Software Testing certification
- Acts as QA lead support to regional Flex Factory (FF)/KUBio projects supporting milestone reviews
- Provides QA Support to Global Flex Factory/KUBio projects as requested
- Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility
- Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance
- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency for the Enterprise solution business
- Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation
Los Angeles, CA
QA Team Leader
Los Angeles, CA
Satterfield Group
Los Angeles, CA
QA Team Leader
- Feeding back issues raised from paperwork checking and/or area inspections to the production management and then the QA Manager in a timely manner
- Work with the returns department to establish a way of working
- Attend daily meetings with the Technical Manager and the Assistant Technical Manager where necessary
- Assist the QA Manager with any customer complaint investigations and close out when requested
- Manage all daily prioritisation, performance and output quality review, coaching, training and internal communications
- Providing feedback to AML Ops team and work on standardisation of alert monitoring process across hub
- Understand and action all quarantine stock daily and report to the QA Manager/Technical Manager
present
Houston, TX
QA Senior Site Leader
Houston, TX
Howell, Schroeder and Balistreri
present
Houston, TX
QA Senior Site Leader
present
- Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews
- Acting as Management Representative for Quality at the Site
- Timely communication of all quality concerns, initiatives, and information to the site Management team
- Operates a Local Inspection program and manages follow up activities to close Nonconformities
- Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
- Acts as Management Representative for Quality at the Site
- Maintains and improves all aspects of Site Quality Planning
Education
Education
Bachelor’s Degree in Computer Engineering
Bachelor’s Degree in Computer Engineering
Howard University
Bachelor’s Degree in Computer Engineering
Skills
Skills
- Excellent communication skills (written and oral)
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
- Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment
- Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)
- Familiarity with principles/concepts of Quality Systems/ISO/Good Laboratory Practices
- Team player, with high ability to work independently
- Strong analytical and trouble-shooting skills
- Ability to multi-task & handle tasks with competing priorities effectively
- Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators
- Good problem identification, multivariable analysis and creative resolution aptitude
12 QA Leader resume templates
Read our complete resume writing guides
1
HBO QA Leader Resume Examples & Samples
- Working with a wide array of groups to understand the agreed upon functionality, how the functionality will work, and how to guide the staff and QA testing vendors to create test cases and scenarios which will fully exercise this functionality
- Partnering with the user community to understand their roadmap and determine testing requirements, and how to best resource those efforts
- Manage on and offshore resources to augment existing staff and deliver high quality, low to zero defect releases
- Assist in the maintenance of appropriate processing flow charts, diagrams, tables, and other supporting documentation to convey proposed or updated testing approaches
2
QA Team Leader Resume Examples & Samples
- Reviewing of transaction monitoring alerts closed by AML Ops Analyst to ensure that quality of review is within the required standards
- Providing feedback to AML Ops team and work on standardisation of alert monitoring process across hub
- Beeing an escalation point for review of complex cases to validate that transaction monitoring alerts have been processed in line with quality standards and/or that QA reviewer reports have been prepared correctly
- Ensuring that the Quality Assurance process is executed in adherence with global standard policies and procedures, using global standard tools
- Line managing for QA SME, including performance management, coaching and supporting hiring and training
- Beeing subject matter expert in AML regulations, systems and reports
- Facilitating QA update sessions- after-review lessons learned
3
Wlo Cb / kyc / qc QA / Team Leader Resume Examples & Samples
- Review and approval of KYC documentation, information, research and Due Diligence Forms (DDFs) that have had deficiencies noted and have been escalated for potential return to market or edit on the Quality Control team
- Minimum 5 years' experience in financial services operations, compliance, risk management or client service preferred
- Strong understanding of AML and BSA regulatory requirements required; CAMS certification is a plus
- Knowledge of wholesale banking products, services and processing for treasury/depository, investments and credit required
4
QA Team Leader Resume Examples & Samples
- Manage the activities of a defined team of QA personal,
- Maintain manufacturing and audit inspection
- Carry out quality inspection training
- Lead, motivate and mentor a team of technicians and engineers
- Degree in Quality, Engineering mechanical / industrial is required
- Proven successful track record managing QA systems in the Medical Device industry
- Strong engineering professional with a keen interest to lead and mentor teams
5
QA Delivery Leader Resume Examples & Samples
- Continuously demonstrate the business value of QA and communicate that business value to cross-functional IT/Business stakeholders
- Provide guidance and direction to on and offshore QA Systems Specialists for ensuring that the highest level of testing services are delivered on time and within approved budget
- Manage the QA Delivery Team’s capacity, demand and resource utilization programs, including management reporting
- Drive a culture of risk identification, evaluation and action based upon the agreed risk appetite with the appropriate project stakeholders
- Drive the development of deeper IP domain knowledge within the team
- Ensure accurate and timely capture of QA metrics
- Ensure high vendor productivity, effectiveness and adherence to SLAs
- Champion the effective usage of automated regression testing suites
- Continuously drive improvement programs for maturing QA capabilities
- Bachelor's degree in Computer Engineering or related field, with a minimum of 5 years of experience in Information Technology Quality Assurance OR in lieu of the Bachelor's degree, a minimum of 9 years of experience in Information Technology Quality Assurance
- Minimum 5 years' experience leading and managing a team of QA professionals
- Minimum 5 years of experience in QA best practices and methodologies to design, implement and automate processes. Coordinating with external QA resources including knowledge of software development life cycles, testing methodologies, and test management/tracking tools such as HP ALM and/or any other defect management tracking tools
- Minimum 2 years of experience with Waterfall and Agile/SCRUM methodology
- Highly organized, detail oriented, extremely responsive and able to prioritize a large number of tasks
- Strong positive attitude and a demonstrated ability to manage large, geographically dispersed teams with confidence
6
QA Process Leader Resume Examples & Samples
- Drive finalization of document inventory to be developed and implemented
- Drive the development/refinement of QA testing methodology policies, standards, procedures and PMO/regulatory related documents
- Collaborate with the PMO on the integration of test PS&Ps into PMO processes
- Establish a testing, consulting/coaching service to improve the quality of all test phases across the enterprise
- Conduct random project document inspections to assess process adherence
- Produce monthly testing metrics reports and utilize the results to drive continuous improvement through collaboration with IT and business project managers and application development teams
- Deliver on strategic programs identified by the QA Leader which are aligned to the technology strategic Initiatives function
- Minimum 5 years of experience leading and managing a team of QA professionals
- Minimum 3 years experience creating and implementing QA testing processes and procedures
- Well-developed oral and written communication skills
- Strong positive attitude and a demonstrated ability to accomplish complicated projects with confidence
7
QA Delivery Leader Resume Examples & Samples
- Minimum 5 years of experience leading and managing a team of QA professionals (i.e. direct reports, offshore resources)
- Experience supporting minimum of 10+ applications in a QA environment
- 3 years of experience delivering QA services in a QA environment that is maturing
- Experience delivering services through a testing vendor including remote teams (offshore resources)
- Experience with building and implementing formal QA services
8
Centralized Lending Unit Credit QA Team Leader Resume Examples & Samples
- 12 years of work experience including audit, operations, process engineering or risk management
- Solid knowledge of SOX and other industry-related regulatory requirements, and operational risk concepts
- Strong Professional communications both written and verbal, presentation skills and relationship management skills
- Demonstrated leadership and influencing skills
- MBA or advanced degree; Consulting experience at a corporate level, Professional certification or license
- Knowledge of related industry or division
9
QA System Team Leader Resume Examples & Samples
- People leading & Mentorship skills
- Creativity in problem solving
- Project MGMT skills / Agile experience
- Self managing abilities
- Great inter-personal & communication skills
10
Global QA & Operational Excellence Leader Resume Examples & Samples
- Design, implement and oversee adherence to processes necessary to maintain the Enterprise quality management system, which meets international standards
- Drive Global Quality Initiatives throughout Life Safety Products
- Provide Operational Metric guidance and performance oversight, supporting analysis and improvement when necessary
- Create and lead a community of quality professionals and Subject Matter Experts
- Develop relationships with customers and factories to improve results; ensure factory capabilities and results meet customer needs; work with customers and factories to resolve problems
- Manage, promote, expedite, and report the deployment of QA initiatives across Life Safety Products
- Ensure & expect the effective use of all the Quality tools across process design, operational management and problem resolution
- Provide a path of escalation for all site and regional Quality Managers and Quality teams
- Partner with Risk Management, Warranty Claims, and manufacturing quality managers to lead activities overseeing enterprise quality issues, root cause investigations, corrective action implementation, etc
- Provide leadership within the Tyco Enterprise Quality Management community
- Create an organizational culture of continuous improvement and "one company" approach
- Organise and chair monthly cost out meetings with-in LSP Globally
- Drive and manage Six Sigma and Lean programs & training throughout the organization
- Drive and facilitate sustainable Lean, Six Sigma culture across the organization
- Identify opportunities & drive performance improvement efforts working with LSP Senior Leadership team, MLT's and functional owners
- Identify & engage talented candidates to become black belts and green belts in the organization
- Mentor and support Black Belts, Green Belts and Lean Leaders through complex projects and problem solving
- Manage Operational Excellence Reporting activities in line with budgetary targets
- Promote and facilitate the successful implementation and execution of the Tyco Business System (TBS)
- Partner with Functions and Operations by applying six sigma and lean principles to drive sustained continuous improvement results
- Coach the team on correct application of lean six sigma a continuous improvement tools by being Black Belt (BB) Certified in the appropriate TBS Tool(s) and viewed as the organization's subject matter expert in TBS
- Support the training and certification of other BB's
- Four year degree in a Technical (Science/Engineering preferred) or Business-related discipline and minimum 10 years related experience. Advanced degree a plus
- Successful experience leading a lean six sigma or equivalent deployment/program
- A proven track record managing multiple projects/programs using Lean Six Sigma methodology in both operational and transactional arenas. Certified Black Belt or equivalent. Master Black Belt experience/certification a plus
- Lean experience required including implementation history in both factory and transactional processes. Basic DFSS knowledge and application with new product development efforts
- Ability to lead and influence in a matrix environment. Proficiency in gathering, analysing and interpreting data. Experience with metrics and scorecard development preferred
- Manufacturing/Supply Chain management experience desired
- Proven Project Management experience and expertise
- Demonstrated ability to function effectively in a fast-paced environment
- Experience with change management techniques
- Demonstrated Experience with working effectively with all levels of an organization
- Ability to develop key metrics, interpret results and develop action plans to improve
11
QA Team Leader Resume Examples & Samples
- Ensure consistent inspection of products in line with ASOS quality standards, working closely with the relevant garment technologist at head office
- Building and maintain strong working relationships with head office garment technologists, processors, the returns department, FC staff and Customer Care@Hemel
- Ensure that all members of the team are trained to the correct standards
- Maintain department KPI’s
- Capture high risk products before it escalates and increases returns
- Work with the returns department to establish a way of working
- Manage the daily performance of the department
- Producing reports for feedback to the business
- Owning Adhoc projects
- Experience and knowledge of working with retailers on quality standards is an advantage but not essential
- Previous warehouse experience is essential
- Building and maintaining stakeholder relationships
- Team player with a can-do attitude
- A natural problem solver with the ability to identify business issues, their impact and quickly drive a suitable solution
- Experience of working in a fast paced fashion business
- Previous experience of designing and running reports is an advantage
- Efficient in Outlook and Microsoft office especially excel
12
QA Leader Resume Examples & Samples
- Experience in problem solving and consultation within complex environments
- Experience in facilitating organization-wide efforts
- Bachelor’s degree and 8 years of IT or testing experience
13
QA Leader Resume Examples & Samples
- Acts as QA lead support to regional Flex Factory (FF)/KUBio projects supporting milestone reviews
- Provides QA Support to Global Flex Factory/KUBio projects as requested
- Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance
- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency for the Enterprise solution business
- Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts
- Ensures readiness of facilities, systems, and operating mechanisms in compliance with GEHC and Life Sciences (LS) requirements
- Coordinate validation protocols and reports from draft to approval
- Support on-site document control, including but not limited to, documents from SAT, Automation, IQ, OQ etc
- Supports Service QA in hosting Customer audits related to Flex Factory/KUBio
- Participates in the establishment of equipment testing documents for FF products
- Conducts trainings, such as GDP, GMP(21 CFR part 210/211, part 820) & document control, to the project team as necessary
- Administers deviations and EngaGE cases in accordance with internal procedure
- Responsible for escalation and categorization of risks associated with teams interactions with customers, third parties, regulators, and operating mechanisms
- Support coordination and oversight of KUBio Qualification
- Supports ad-hoc assignment based on business need
- Bachelor’s degree, plus 5 years work experience
- 3 years Quality Assurance/Regulatory Assurance experience in a regulated industry or a Masters degree
- Ability to communicate effectively in English (both written and oral)
- Demonstrated validation experience in pharmaceutical or medical device industry
- Familiarity with HVAC system, WFI, PW and automation for environmental monitoring requirements
- Demonstrated understanding or aptitude to understand Medical Device QMS & Pharmaceutical GMP regulatory requirements including but not limited to FDA CFR 21 820, 210/11, ISO9001 & ISO13485
- Ability to travel and work at customer site based on needs from different project phases
- Knowledge & experience of ISO14644 cleanroom requirements
- Experience in ISPE, GAMP5 and GMP requirements
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
- Experience performing internal audits and participating in external audits
- Exceptional analytical, problem solving & root-cause analysis skills
14
QA Leader Resume Examples & Samples
- Maintaining and improving all aspects of Site Quality Planning
- Overseeing all Quality-related communications and training requirements for all site employees
- Establishing positive relationships with outside agencies
- Hosting Quality System audits and inspections
- Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering
- Driving the definition of site quality objectives, metrics, reporting and operating mechanisms
- Operates a Local Inspection program and manages f/up activities to close NCs
- Maintain full Quality System Regulations and Current Good Manufacturing Practices Requirements ensuring compliance to regulations and legal requirements through successful and effective quality management systems
- Timely communication of all quality concerns, initiatives, and information to the site Management team
- Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 7 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment)
- Minimum 1 years supervisory/ management experience, including hiring, training, coaching and performance management activities
- Hands-on experience with FDA, CFDA， QSR, ISO, MDD and/or other international quality systems requirements
- Proven track record in performing external and internal audits
- Proven process development and project management skills
- Professional certification as a Lead Auditor
15
Project Leader QA Resume Examples & Samples
- Good business acumen
- Strong leadership characteristics and project management skills
- Understanding of manufacturing operations and application of Good Manufacturing Practices (GMPs)
- Experience with Quality Systems and processes such as Good Documentation Practices (GDP), Good Laboratory Practices (GLP), CAPA, Management Review, Change Control, etc
- Strong interpersonal, communication (verbal and written), influencing, and negotiation skills
- Strong computer, data organization, and presentation skills (MS Excel, MS PowerPoint, MS Word, MS SharePoint)
16
Computerized Systems QA Leader Resume Examples & Samples
- Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines
- Authorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests
- Conduct audits of global computerized system vendors and 3rd party software providers, including SaaS
- Proactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data
- Plan, execute and report on internal audits of activities, records and processes related to regulated computerized systems and regulated data
- Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards
- Minimum 4 years experience working with IT systems and teams
- Experience with all phases of software validation and infrastructure qualification
- Demonstrated multitasking project management and execution skills
- Excellent verbal and written communication skills at the functional and technical level
17
QA Leader North & East Africa Resume Examples & Samples
- Participate in the development and maintenance of the region Quality Management System (QMS) and relevant processes to assure product quality and safety
- Ensure company procedures and proper documentation practices are followed per GE Healthcare QMS requirements
- Conduct periodically regional QMS and metrics reviews with region top management
- Coach and mentor functional teams on the development, maintenance and simplification of local procedures
- Provide advice & counsel to business managers in the region
- Assist the Quality Assurance Site Manager (when applicable) in preparation for internal/external audits and implementation of corrective actions to address non-conformities
- Work closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) to ensure compliance to applicable regulations and drive product quality in the areas of Design, Service and Manufacturing (when applicable)
- Lead and support continuous improvement activities assigned, which may include such areas as: Standards compliance, Risk management, and metrics development/implementation
- As appropriate, recruit, mentor, coach & train direct and indirect reports, as well as distributors on activities within areas of responsibility
- Complete all management reviews in accordance with management controls procedures
- Support timely closure of customer complaints, field actions, and quality system non-conformances in partnership with functional teams
- Business Fluency in Arabic and English both spoken and written
- Hands-on experience with FDA 21CFR820, QSR, ISO9001 and 13485, MDD and/or other international quality systems requirements
- Experience in a global, matrixed organization structure
18
QA Team Leader Resume Examples & Samples
- Implementing/Maintenaing the solution testing framework
- Implement UI and API test automation
- Certifying the solution releases
19
QA Leader Quality Release Resume Examples & Samples
- Lead the Product Release team and others by providing direction and guidance
- Responsible for the control and ultimate disposition for manufactured product from the site. Provides release decisions at the Durham site for materials designated for both international and domestic distribution and facilitates appropriate communication thereof to receiving packaging site
- Assign final batch disposition for incoming materials/components, culture media, and filled product after a thorough assessment of the release inputs
- Authorized signature for CBER and International release protocols
- Is thoroughly knowledgeable concerning Quality Assurance activities and manages the operation in accordance with company policy and applicable government regulations in a timely manner
- Author, review, and approve Investigational, CAPA, and Batch note Quality Notifications (QNs)
- Author, review, and approve SOPs
- Take on project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management
- Train employees on new or revised processes or procedures
- Determine staffing needs and hire to meet those demands
- Review and approve LIMS rejections
- Review and approve Vendor Change Notifications and BOM changes
- Review and approve Operation, Technology, or Automation protocols
- Devise strategy that provides short and long term solutions to managing the team and meeting demands
- Participation in Kaizen events
- Actively participates in World Class Supply Initiatives with other site functional groups, such as the Quality Laboratory, Manufacturing Operations, and cross- site packaging groups
- Performs the duties and responsibilities of the Quality Director in his/her absence. Acts as a key Subject Matter Expert for release related matters in order to interface with regulatory agencies during audits. Assist, when delegated, in ensuring regulatory commitments are satisfactorily addressed
- May serve as team leader for schedule adherence and prioritization of release of both domestic and/or international batches to ensure minimal interruption to supply and metrics
- Accountable for the performance of work group
- CGMP experience within a pharmaceutical operation complying with both domestic and international regulations
- Minimum of 8 years experience in pharmaceutical operations, technical services, and/or quality operations with at least 5 years in a quality function
- Managerial experience over a staff of 5 or greater
- Quality Control and/or Quality Assurance experience
- Prior experience with the domestic and international release of product
- Ability to lead and manage process improvement projects in a culture of continuous improvement
- Minimum of 2 years managerial experience recommended
20
QA Leader Resume Examples & Samples
- Reviewed in conjunction with the manager the existing standards of production are satisfactory and follow safety regulations. Also helps the Manager to check the past records of production to review if the existing standards will continue to bring in more customers
- Lead group of workers to achieve Department and Company goal
- Report all abnormalities detected
- Keep records filed orderly and maintained at all times
- Maintain QA areas to be auditable at all times for ISO and customer compliance
- Ensure only certified QA inspectors work on product specifications and requirements
- Ensure all shipment buy off activities are conducted effectively and within the stipulated requirements
- Review some business statistics
- Determine and document any areas that may need improvement
- Inspect and sample the entire manufacturing process
- Review the current policies and improvise plans to improve upon the existing quality standards
- Review and analyze the effectiveness of the modifications made
- Ensure that all procedures within the company conform to health and safety regulations, financial policies and legislation such as equal opportunity
- Help the manager to educate the sales and marketing departments regarding the specific requirements of clients
- Ability to compute rate, ratio and percent and to draw and interpret bar graphs
- Demonstrates technical skills. Requires basic competency related to function
- Basic understanding of typical quality tools, such as 8d, statistical process control, FEMA and control plans
- ISO/FDA Auditing experience a plus
- Use of the following tools may be required: Office Skills: telephones, data entry, office software to include word processing, spreadsheet, and presentation package
21
TAS Health & Welfare QA Team Leader Resume Examples & Samples
- Work and partner with Manila and H&W QA leadership to identify issues, risks, inefficiencies, and improvement areas and define how to address such areas
- Know and understand the company’s product and how it is meant to work; then implement strategies that ensure features and functionalities are properly tested and work as intended
- Identify product issues and work to prioritize and plan resolutions
- Ensure teams are complying with WTW Professional Excellence, ISO 9001 and ISO 27001 policies and procedures and adopting QA standard tools and processes. Assists in developing standardized work processes, tools, and methodologies that improve quality and efficiency
- Oversee team performance against established quality, security, efficiency and client delivery standards. Be a partner to leadership in identifying and mitigating risks related to these standards
- Set goals, determine schedules, and drive consistency of team methodology, process and deliverables. Measure progress against objectives
- Contribute in the establishment of best practices consistent with industry and quality standards
- Be a SME on critical QA disciplines and best practices. Provide leadership and mentoring to Quality Analysts on the following
22
QA Team Leader Resume Examples & Samples
- Proved experience in a high risk/care chilled production environment
- Extensive knowledge of Food legislation, safety and quality
- High Risk Microbiological Understanding
- An operational knowledge of Windows software systems
- Graduate or higher qualification in food related subject
- Communication skills – for confident & professional liaison with internal & external customers
23
QA Leader Resume Examples & Samples
- Leads process efficiency and compliance effectiveness through the implementation of the site’s Quality Management System
- Minimum of 1 year experience working in a regulated industry or a Master’s degree
- Minimum of 3 years’ experience in a regulated industry is preferred
24
QA Team Leader Resume Examples & Samples
- Supervise and manage the QA staff on a day to day basis
- Undertake to ensure that all new starters are given full and sufficient training and that existing QA staff are given ongoing training and development where necessary
- Ensure that the process of manufacture is audited against the agreed standards
- Provide a quality audit function to the factory
- Ensure that the Cranswick traceability system is correctly operated through all stages of production manufacture from raw material intake to finished product despatch
- Ensure raw materials arriving in the department are of a specified quality and standard
- Issue the Technical Manager with a daily summary of non-conformance incidents that have arisen and any other information required
- Competent in the operation and programming of all relevant machinery and the maintenance of equipment such as calibration for example
- Assist the with customer site visits and other third party audits
- Attend daily meetings with the Technical Manager and the Assistant Technical Manager where necessary
- Responsibility for complaints investigation and KPI data collection
- Root Cause Analysis for Non-conformances and Complaints
25
Global Software Delivery Performance & QA Leader Resume Examples & Samples
- Perform as Business Analyst to evaluate project data to determine process and tool modifications allowing integrated functions of the global organization to efficiently serve customers
- Design and provide project metric reports to monitor revenue milestones and defect detection effectiveness
- Lead design workshops with diverse groups of engineering leads to converge on the global standard for system delivery processes and tools
- Support project teams in the usage of the Application Lifecycle Management tool (GridIQ Project)
- Evangelize quality across software delivery business units worldwide by delivering hands on tool workshops, driving continuous improvement, and ensuring process conformance
- Support the Product Owner for Application Lifecycle Management tool (GridIQ Project) for Software Delivery in making prioritization decisions related to global use of the tool
- Continuously create and communicate documentation and training for process and tool changes
- Support testing efforts for internal software delivery tools
- Act as main change agent in supporting the team
- 5 years’ experience in quality, continuous improvement
- 5 years’ experience in software development and delivery of integrated systems including the application lifecycle management process
- Open for change and willingness to drive change within large and distributed teams
- Very good written and oral communication skills
- Experience with Atlassian JIRA is important
- Ready to work on non-business hours due to multi time zones interactions
26
Td-QA Leader Resume Examples & Samples
- Establishing, maintaining and improving QMS of medical device trade company to meet CFDA GSP and ISO13485/9001 requirements
- Accountable for assisting the Quality Assurance Site Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection
- Responsible for managing processes and procedures to assure product quality and safety
- Supporting local programs and quality issue resolution
- Maintaining data in Shanghai CFDA Medical Device Traceability System
- Influencing site compliance to Quality policy, Quality Management System procedures
- Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics
- Demonstrated experience in the medical device or pharmaceutical industry and knowledge of CFDA quality system regulations and policies
- Experience with some or all of the following
- Prior experience using word processing, spreadsheet, and presentation software
- Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
- Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
- Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
- Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience)
- 3 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance
- 1 year experience managing people (if QA Leader will have direct reports)
27
Performance Improvement & QA Leader Resume Examples & Samples
- Degree or equivalent
- Chartered Engineer or equivalent - desirable
- Appropriate qualification in quality audits
- Lean Six Sigma certification or appropriate experience
- Extensive experience in performance management, improvement, innovation, quality and compliance
- Demonstrable capability to lead improved and compliant business performance in a challenging environment
- Experience in leading delivery in a customer-service focused contract that demonstrates improving customer satisfaction
- Working under a quality management system along with the impact of audit regimes
- A strong focus on improvement, lean, quality systems & change management
- The application of Lean methodology
- Leading and managing change
- Experience of successful matrix management
- Detailed understanding of the Highways England asset support contract, would be very advantageous
28
QA Team Leader Resume Examples & Samples
- Management of QA’s on PM shift
- Complete factory walk rounds with the QAs on a daily basis
- Understand and action all quarantine stock daily and report to the QA Manager/Technical Manager
- Monitoring raw material sampling to ensure compliance with all sampling schedule to protect the safety of our products through food safety checks on incoming materials
- To report any non-conformance to relevant managers
- Assist the Compliance officer with the completion of all yearly shelf life and validation as indicated upon on schedules
- Ensuring all schedules that are in place are adhered to i.e. allergen, speciation, micro and DNA
- To assist the training of production team leaders with regards to any CCP changes
- To carry out CCP audits are on a weekly basis
- Carry out procedure challenges on a weekly basis and document any non-conformances regarding processes and procedures not being followed
- To carry out Monthly Foreign Body audits
- Assist the QA Manager with any customer complaint investigations and close out when requested
- Ensuring the maintenance, development, review and effective communication of the QMS
- Liaises with product development during production trials, preproduction and launches
- Following up all non-conformance issues arising from paperwork, with production personnel or via other technical personnel as appropriate
- To carry out other duties such as specific projects as required by the QA / Technical Manager
- Proven experience in a high risk/care chilled production environment
29
Group Leader QA Qualification Resume Examples & Samples
- Maintenance and improvement of the existing systems to ensure lean, effective systems
- Works with other departments to reinforce and embed a culture of quality and ensuring compliance with current GMP and ISO regulations
- Identifies any areas of compliance vulnerability end ensures preparedness for inspections within the field of responsibility
- Preparation, review and approval of relevant VMPs, SOPs and other qualification documents
- Ensuring that deviations are adequately investigated and documented and QA approval of major deviations in qualification/EM
- Ensuring that qualification and monitoring activities are professionally and competently presented in audits and inspections
- Provide guidance on the scope and depth of qualification activities to project teams
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QA R&D Project Leader Resume Examples & Samples
- Coordinates QA activities in product development projects as Core Team member
- Establishes and maintains Quality Plans in development projects to cover QA aspects related to product design, product development and quality metrics
- Monitors and reviews timely and effective execution of the Quality plan including fulfillment of quality metrics
- Evaluates CAPAs, NCRs production and post-production information from current products and ensures that this information is used as input to product development
- Periodically reports to Manager QA R&D in Lund on the status of activities under their responsibility
- Participates in Design Reviews
- Participates during audits/inspections
- Reviews and approves Verification and Validation activities, including planning and protocols
- Reviews and approves Design Review Reports
- Rejects and vetoes deliverables which are not adequate, nor based on objective evidence
- Rejects and vetoes Design reviews, if needed
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Partner Support Center QA Team Leader Resume Examples & Samples
- At least 3 years of experience in a call center environment, in which being a team leader for at least one year
- Positive and professional attitude
- Has critical thinking skills
- Ability to analyse the root cause of issue and able to design action plan
- Ability to work independently and also part of the team
- Ability to multitask accordingly
- Ability to interact with people of diverse cultures and backgrounds
- Ability to be creative and innovative in completing the given task
- Willing to accept and adapt to changes and undertake new challenges
- Willing to work towards targets and goals set by the organization
- Willing to work in a team with positive and enthusiastic attitude
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Computerized Systems, QA Leader Resume Examples & Samples
- Promote and champion support of compliance, quality and best practice oriented culture regarding computerized systems
- Support the development of global CS QA related procedures
- Participate in ongoing operational management activities for global systems including but not limited to demand management, Change Advisory Board and Quality Metrics
- Provide expertise and support during audits and inspections of Takeda
- Proactively identify risks and issues. Drive implementation of pragmatic, compliant, quality based solutions
- Lead on-going initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned
- Support the response and remediation of corrective actions and internal audits
- Bachelor degree in Science, Business, Engineering, IT or related discipline or 5 years equivalent professional experience
- Minimum 6 years experience with FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements
- Experience making quality assurance and compliance decisions in regards to software development, validation and support
- Experience with all phases of System Development Lifecycles principles, processes and procedures
- Ability to read, analyze and interpret business plans, technical procedures, and government regulations
- Proven analytical and problem resolution skills; ability to identify root cause of problems
- Ability to understand complex business processes and recommend simplification where possible
- Documented experience in working as part of a "virtual” team
- Proficient in Microsoft Office products (Word, Excel, PowerPoint, Project and Visio)
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QA Senior Site Leader Resume Examples & Samples
- Directing the Site Quality Management System, fully integrated into the GE Global Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization
- Responsible for building the right quality culture, hiring quality resources, building capabilities of team & processes and set up world class locomotive manufacturing unit
- Ensuring site audit readiness and hosting Quality System audits and inspections
- Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
- Participating in selected global initiatives to share best practices and leverage quality synergies
- Supporting local R&D programs and quality issue resolution
- Acting as Management Representative for Quality at the Site
- Aware of and comply with the GET Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Identify and ensure timely closure of corrective and preventive actions for the site
- Mentor and coach direct reports to successful understanding and implementation of Quality System Requirements
- Bachelor's degree in Engineering,
- Minimum 15 years professional experience and understanding of product development, manufacturing, quality control and servicing automotive, heavy fabrication units
- Hands-on experience with ISO, MDD and/or other international quality systems requirements
- Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations
- Good problem identification, multivariable analysis and creative resolution aptitude
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QA Leader Resume Examples & Samples
- Drive uniformity in process/procedures/working practices
- Pro-active collaboration, advice and decision making in granting project/product milestones (engineering)
- Responsible to withdraw non confirming products and stop/release production/shipments (engineering)
- Motivate the organisation to think Quality. Highlight excellent examples/behaviour
- Ensure customer satisfaction/compliance on Quality standards/commitments
- At least 5 years of relevant experience, preferably in a related industry
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QA Leader Resume Examples & Samples
- Responsible for on-time delivery of the team’s tasks, according to a pre-defined plan and quality criteria
- Actively manage the Testing Team on a day-to-day basis, facilitating the work of the team
- Manage Manual as well as Automation Testing coverage by insuring Full Regression with maximum automation coverage
- Lead and conduct Continuous Improvement processes for different teams through analysis of issues coming from the field
- Build a maintain highly engaged team across multiple development sites and with matrix management relationship
- Provide effort estimations, due dates, and planning of activities of the group
- Responsible for the quality of Test Cases – provide business and technical guidance during the process of test design
- Management of testing execution – work as technical focal point and ensure that the progress is according to the predefined timeline and quality requirements
- Provide progress status reports, resolve conflicts and raise flags about outstanding issues that should be escalated for mitigation
- Responsible for personal development and constant improvement of the QA Team knowledge
- Maintain close cooperation with development team, manage the defect qualification according to the set priority, manage defect and ”as-designed” calls, Lead in integration testing with external vendors
- Performs AQ Engineer tasks and duties as required (Up to 30% Hands-on)
- Responsible for integrating automated tests processes into the QA life cycle
- Ability to work under pressure with extreme deadlines and in dynamic environment – must
- Fluent English (both in writing and speaking)
- Relevant experience from R&D / Product and large delivery companies
- Understanding of different Software Development and Testing Methodologies (Agile and Waterfall)
- Team player, with high ability to work independently
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QA Senior Site Leader Resume Examples & Samples
- Accountable for ensuring full quality and regulatory compliance of the Uppsala BioProcess manufacturing facility, while driving process effectiveness and efficiency at the site
- Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews
- Maintains and improves all aspects of Site Quality Planning
- Oversees all Quality-related communications and training requirements for all site employees
- Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
- Ensures site audit readiness and hosting Quality System audits and inspections
- Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs
- Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
- Drives the definition of site quality objectives, metrics, reporting and operating mechanisms
- Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters
- Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
- Participates in selected global initiatives to share best practices and leverage quality synergies
- Supports local NPI programs and quality issue resolution
- Acts as Management Representative for Quality at the Site
- University Degree with a technical background
- Minimum of significant years working in a regulated medical device or pharmaceutical industry
- Minimum of some years supervisory/management or project leadership experience
- Excellent communication skills in both Swedish and English (written and oral)
- Demonstrated understanding or aptitude to understand Biopharmaceutical & Medical Device QMS requirements, regulatory requirements & industry guidance, including but not limited to; US-FDA 21 CFR 820, 210, 210, ISO 9001 & ISO 13485
- Experience of FDA, QSR, ISO, MDD and/or other international quality systems requirements
- Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions
- Demonstrated working knowledge to effectively communicate within all levels of the organization
- Demonstrated collaboration & conflict resolution skills
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Service QA Leader Resume Examples & Samples
- Responsible for establishing and managing processes and procedures related to existing and new business models to assure product quality and safety
- Assist the Service Quality Manager to establish, maintain and improve QMS of GEHC China Service to ISO13485/9001 requirements and other regulations’ requirements (like GSP)
- Accountable for assisting the Service Quality Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection
- Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
- Support QMS management reviews and risk assessments
- Planning and conducting internal audits
- Facilitating Internal and external audits assigned within China Service region
- Supporting China Service programs and quality issue resolution
- Support China Service to compliance with FDA/CFDA etc. regulations and all kinds of audits
- Conduct internal audit tasks and lead cross-functional teams to drive closure of audit findings/high risk activities through CAPA process
- Deliver Specific QMS training and Promote culture building, drive improvement and raise employees’ awareness
- Demonstrated experience in the medical device or pharmaceutical industry and knowledge of ISO 9001 &ISO 13485, CFDA quality system regulations and policies
- Demonstrated ability to successfully comprehend & carry out/execute actions
- Effective oral and written communication skills
- Analytical & problem-solving skills/root-cause analysis
- Exceptional conflict-resolution skills
- Ability to prioritize and drive multiple programs
- Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
- Can travel within China
- Bachelor’s degree (or high school diploma/GED plus 5 years experience work experience)
- Above 5 years’ experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance
- Ability to effectively communicate using English
- Project management skill
- GB certified candidate
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QA Program Leader Resume Examples & Samples
- Directs and enhances organizational initiatives by positively influencing and supporting change management and/or departmental/enterprise initiatives within assigned area(s) of responsibility
- Identifies and directs the implementation of process improvements that significantly reduce workloads or improve quality across the department for his/her assigned area(s) of responsibility
- Provides subject matter expertise to team members and internal/external stakeholders on complex assignments/projects for his/her assigned area(s) of responsibility
- Provides training and development opportunities, including stretch assignments, for team members and gives honest and open feedback to aid in the development of talent
- Directs and evaluates individual/team performance and takes appropriate action to meet and/or exceed performance standards for assigned area(s) of responsibility
- Establishes and implements priorities, performance goals and objectives to ensure group results for his/her assigned area(s) of responsibility
- Directs and provides leadership to continually improve the capability and results for his/her assigned area(s) of responsibility
- Ensures that top talent is hired and retained for his/her assigned area(s) of responsibility
- Builds organizational capability within his/her assigned area(s) of responsibility
- Partners with stakeholders and senior leadership in developing quality and testing initiatives that satisfy the company’s objectives
- Provides clear definition of roles and responsibilities to project team members
- Defines and directs acceptable level of quality for testing deliverables at each level (e.g. functional, system integration, acceptance and regression)
- Oversees and promotes test automation to maximize Line of Business (LOB)/program efficiencies
- Ensures and/or designs complex business requirements for test data management to assure data security
- Defines metrics & Service Level Agreements (SLAs) to measure the performance of QA activities
- Improves control of costs, standards, and quality by monitoring the Managed Services Provider’s (MSP) results and quality deliverables
- Collaborates with internal/external stakeholders to develop process improvements and/or talent development that will enable more effective delivery of change
- Collaborates with Test Leads to ensure the business objectives and goals are communicated clearly within each project
- Collaborates effectively with appropriate stakeholders and management on complex issues and conflicts that impact quality deliverables and milestones
- Reviews the quality audit results with the Test Leads and determines a course of action for any items not meeting quality standards
- Serves as a Quality Assurance subject matter expert between area of responsibility and appropriate stakeholders to bridge gaps and resolve differences between stakeholders (e.g. MSP, IT and Business partners) and to form a clear two-way interface channel
- Verifies the MSP is satisfying the deliverables as previously communicated and agreed upon
- Ensures compliance to best practices as defined by the QA Center of Excellence, Automation Center of Excellence and the Enterprise Project Management Organization (ePMO)
- Reviews and certifies QA estimates (including automation and those for interfacing systems) developed by Team Leads
- Drives change initiatives to implement more efficient and Agile testing policies and approaches
- 7+ Years of experience in QA Software Testing that directly aligns with the specific responsibilities for this position, including 3 + years of managerial, supervisory, and/or demonstrated leadership experience (Required)
- Experience leading teams practicing BDD/ATDD using Cucumber and Selenium based tools
- Experience with Service virtualization tool(s)
- Experience with DevOps methodologies, specifically around Continuous Integration and Continuous Testing
- Experience with cloud based environments and tools that support infrastructure as code
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QA Leader Resume Examples & Samples
- Leading team members with shift responsibilities in fulfilling requirements of the business and in support of production to meet manufacturing strategies and/or obligations
- Managing resources and workload demand requirements in order to meet production, testing and sampling requirements of various functional groups to achieve production, quality, and productivity initiatives
- Providing technical support to production on quality issues
- Developing and monitoring key, actionable measures with group members to assess performance, identify additional activities and/or requirements and link to factory/manufacturing-wide objectives
- Determining and assisting in the development/implementation of plans to meet group and individual development requirements; including technical equipment training, sampling processes and product conformity identification
- Developing and sharing relevant information, trends, regulatory and/or requirement changes to focus problem solving, continuous improvement and ongoing development
- Negotiating and building consensus for resource needs, problem solving and solutions with peers, subordinates and management
- Demonstrating knowledge of federal and US Smokeless Tobacco guidelines for proper handling and storage and distribution of licensed material
- Bachelor's degree in Business, Engineering, Science, related field and/or equivalent experience in scientific/business fields
- Minimum of 3 years of supervisory experience within a manufacturing environment
- Familiarity with principles/concepts of Quality Systems/ISO/Good Laboratory Practices
- Managerial and performance management skills as well as planning, organizing, facilitating and communicating with all levels of matrix organization
- Must be able to work well in a team environment and have demonstrated strong project management, verbal, written, and general communications skills
- Proficient with MS Office (Word, Excel, PowerPoint, Outlook), and familiarity with Laboratory Information Management System (LIMS), and SAP
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Data & Analytics BA / QA Leader Resume Examples & Samples
- 3+ years of formal experience in an IT Business Analyst or IT Quality Assurance Analyst role preferred
- Formal HR leadership experience is preferred
- Experience leading BA/QA discipline best practice advancement including requirements and test planning through execution in an Agile environment preferred
- Demonstrate the ability to embrace and understand the change process and effectively guide others through change
- Excellent leadership, oral and written communication, planning, and decision-making skills
- Demonstrated facilitation, interviewing and negotiation skills
- Strong analytical, problem-solving and big-picture/conceptual skills
- Strong initiative, results oriented and can meet pre-established deadlines with minimal supervision
- Must be able to work with people at all levels and be able to influence others without formal authority
- Must be able to build and maintain relationships and facilitate collaboration and communication
