Design Quality Engineer II

• Part of a team, completing Quality tasks in the design and development, and change control processes.

• Ensure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR).
• Review, maintain and approve Design History Files (DHF) and Risk Management Files (RMF).
• Identify and mitigate design risks using FMEA and other tools.
• Support design verification and validation activities.
• Supports design and change control processes.
• Collaborate with design teams to embed quality standards.
• Author, review and approve documentation in Quality capacity.
• Define and control Critical to Quality (CTQ) characteristics.
• Assist with regulatory submissions and audits.
• Analyze quality data to identify trends and improvement areas.
• Support quality improvement initiatives.
• Support root cause investigations and CAPA activities.
• Supports design transfer and sourcing transfers with Supplier Quality counterparts.
• Supports customer complaints investigations.
• Management of product nonconformance, hold and field action records and activities.

• Proficient in design controls, verification, validation (design, process and software).
• Working knowledge of FDA 21 CFR 820.30, ISO 13485, and EU MDR.
• Understanding of risk management (ISO 14971, FMEA, statistical tools).
• Capable in V&V planning and execution including human factors usability studies.
• Proficient in statistical data analysis.
• Effective cross-functional communicator.
• Excellent technical writing skills.

• Microsoft Office
• Windchill
• Code beamer
• Jira
• Minitab
• GitHub

• B.S. in Engineering or related field.
• 2+ years in Quality Engineering or equivalent medical device experience.
• Solid foundation in engineering principles.
• Equivalent education/experience combinations considered.
• Fluent in written and spoken English.
• Six Sigma Yellow or Green Belt Preferred

Zimmerbiomet