Product Design Quality Sr II

About the role

Product Design Quality Sr II or Sr III Engineer Product Design Quality Sr II or Sr III Engineer Ensures Zimmer Biomet and compatible products meet regulatory, quality, and customer requirements throughout the design and development process, and product lifecycle. Collaborates cross-functionally and with external partners to achieve Zimmer Biomet’s quality and business objectives.

What you'll do

• Works as part of a team and individually, completing Quality tasks in the design and development, and change control processes
• Coaches and mentors less experienced peers
• Represents Quality team in site meetings
• Creates project and resource plans for small scale, low complexity projects
• Ensure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, IEC 60601, IEC 62304)

What you need

• 5–7 yrs of experience
• FMEA
• Regulatory affairs
• ISO 9001
• Root cause analysis
• Test cases
• Any graduate

Good to have

• Six Sigma