Post-Market Quality Engineer

Stryker • Portage, MI

3d • Hybrid

About The Position

As a Post-Market Quality Engineer, you will play a critical role in strengthening product reliability across the lifecycle, from post-market insights to product improvements that shape future innovations. This role offers meaningful impact, cross-functional collaboration, and the opportunity to influence products used by healthcare professionals worldwide. Work Flexibility: Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.

Requirements

• Bachelor’s degree in engineering, or related technical discipline.

Nice To Haves

• Experience in quality engineering, post-market quality, regulatory compliance, or a related field.
• Experience working with regulatory authorities such as the U.S. Food and Drug Administration.
• Experience conducting risk analysis and root cause investigations.
• Experience performing and interpreting statistical data analysis.

Responsibilities

• Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities.
• Analyze and trend post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership.
• Update risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness.
• Participate in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions.
• Initiate, track, and document commercial product holds, ensuring timely resolution and accurate records.
• Support business units and commercial teams by providing post-market quality expertise and technical guidance.
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards.
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards, including reviewing change documentation for technical robustness.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level