Senior Engineer, Quality Assurance

Stryker • Redmond, WA

3d • Hybrid

About The Position

Stryker is hiring a Senior Quality Assurance Engineer for its Emergency Care team. This high-impact role focuses on leading critical investigations and driving improvements that support patient safety and product performance across the product lifecycle. The position is hybrid, with candidates required to live within commuting distance of Redmond, Washington, or Portage, Michigan, and work onsite several times 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 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.
• Conduct post-market health risk assessments and health hazard evaluations to assess 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