Job Details

• Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Lead usability, reliability, testing, verification and validation testing. Work closely with regulatory team to drive alignment of project documentation and regulatory requirements. Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
• Suppliers: Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables. Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Uses diplomacy and tact to resolve difficult situations.
• Audit Support: Support internal and external regulatory audits.
• Product Support: Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques and evaluation criteria for obtaining results. Provide quality and compliance input and coaching for new product development activities, such as design changes, product CE marking and safety certification, NCEP’s, CAPA’s. Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).

• 9-11+ years of experience in medical device quality engineering,.
• Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
• Sound understanding of medical device regulatory requirements for Class II and III medical devices.
• Project planning – resourcing, timelines, quality and budgets.
• Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
• Preference for candidates with CQE certification or similar training and experience
• Proficient in project management tools like MS project.
• Experience in GD&T
• Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.

Reference ID - GH/Technology/JC//04092019//86336/Lead Engineer - Design Quality Assurance