Senior Staff Design Quality Engineer

Responsibilities

• Design Quality Leadership
• Represent the Quality function on product/process development teams.
• Mentor other disciplines as needed in the Quality Engineering methodology.
• Ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, design reviews, and design changes.
• May serve as independent reviewer during design reviews, or conduct DHF audits, as required.
• Owner/Approver of one or more processes within the scope of Design Quality.
• Supplier Engagement
• Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.
• Manage supplier to ensure all quality and manufacturing elements supporting final components are qualified at the supplier and on time utilizing PPAP tool.
• Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.
• Review/Approval of PPAP.
• May serve as PPAP lead.
• CAPA/Non conformances/HHE
• Lead or Participate in the investigation of complex product problems.
• Evaluates and disposes nonconforming materials and products used in pilot and clinical builds.
• Conducts or supports health risk assessments in support of the Health Hazard Evaluation, Reporting or Recall processes.
• Design
• Participate in design reviews to evaluate designs, ensure DHF completeness and accuracy, and to help identify alternative design solutions.
• Hands on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.
• Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Contributes to design input requirements as a result of risk analysis, from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
• Approves deviations and design changes, conducts impact assessments, and defines/approves change implementation plans.
• Verification & Validation
• Participate in the development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.
• Creation, evaluation, and validation of product and process test methods.
• Apply statistical techniques in sample size determination and data analysis.
• Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Risk Management
• Defines risk management strategy throughout product lifecycle including construction of the Risk Management File, Risk Management Planning, and benefit-risk evaluations.
• Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools, ensuring effective integration of risk activities throughout product realization process and feedback into design inputs, improvements and maintenance of the product risk profile.
• This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
• Process Improvement and Project Management
• Leads strategic initiatives as aligned with organizational quality objectives.
• May manage a crossfunctional team to execute plans.
• Actively identifies and leads opportunities for improvements across all cross functional departments.
• Promotes continuous improvement in design control and risk management activities and use of quality tools with design team and other departments.
• Regulatory
• Comply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• Implement new or updated standards into existing procedures.
• Represent Cooper as needed in FDA, notified body, internal, and other audits.
• Technical Mentorship
• Serve as a technical mentor to QEs, providing guidance on complex quality engineering topics.
• Promote continuous improvement and consistent application of design quality tools and methodologies.
• Acts as a recognized subject matter expert in one or more DQE domains across the organization.
• Thorough knowledge of statistics and how to apply, evaluate, and provide recommendation from the data.

Qualifications

• Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR.
• Demonstrated knowledge in the application of medical device design controls, verification/validation, risk management principles per ISO 14971, and the use of risk assessment tools such as FMEA, Hazard Analysis.
• Intermediate skill in the use of Excel, Word and PowerPoint.
• Advanced preferred.
• Ability to read and understand highly technical material.
• Proficient in reading and writing in English.
• Self-motivated and committed to a team approach.
• Strong interpersonal, organizational and project management skills.
• Ability and experience interfacing with senior leadership and external stakeholders.
• Strong oral, presentation and technical writing skills.
• Demonstrated skills in decision making, problem solving, negotiation, and influencing without direct authority preferably across a broad spectrum of Quality Engineering responsibilities.
• Proven experience leading cross-functional teams in a medical device development environment.
• Experience with Change Control, Non-conformance, Deviation, Complaints, HHEs and/or CAPAs.
• Strong analytical and problem-solving skills with acute attention to detail.
• Excellent communication and interpersonal skills.
• Knowledge in application of IEC 62304 a plus.
• Knowledge in one or more IEC 60601, ISO 10993, IEC 62366, ISO 11607, ISO 11137 or ISO 11135 preferred.
• Knowledge in application of biocompatibility and/or sterilization standards for medical devices.