Quality Engineer I

About the role

The Quality Engineer is an entry level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.

What you'll do

• 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

What you need

• 0–3 yrs of experience
• FMEA
• Regulatory affairs
• Any graduate