Senior Engineer, Quality Assurance

Stryker • Portage, MI

2d • Hybrid

About The Position

The Senior Quality Assurance Engineer leads critical investigations for Emergency Care and drives improvements for the Belfast, Northern Ireland site. The role focuses on solving complex quality problems and ensuring quality excellence and patient safety across the product lifecycle. It is based in a hybrid arrangement; candidates must live within commuting distance of Portage, Michigan, and work onsite several days per week. Travel is 20%.

Requirements

• Bachelor’s degree in science, engineering, or a related discipline.
• At least 2 years of experience in quality assurance or customer quality.
• Experience working in a regulated industry, such as medical devices or aerospace.
• Experience conducting post-market quality assessments.

Nice To Haves

• Master’s degree in science, engineering, or a related discipline.
• Experience conducting product field actions.
• Experience working with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements.
• Six Sigma Green Belt certification or experience with formal investigative techniques.

Responsibilities

• Lead product field action assessments from initiation through review and approval, ensuring complete, accurate, and timely documentation.
• Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods.
• Perform post-market health risk assessments and health hazard evaluations to assess potential product and patient safety risks.
• Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data.
• Author and manage nonconformance and corrective and preventive action records, including deliverables, action owners, timelines, and supporting documentation.
• Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams.
• Represent Quality Assurance processes during internal and external audits and maintain compliance with applicable quality system, risk management, and post-market requirements.

What This Job Offers

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