Senior Quality Assurance Engineer – Medical Devices (Hybrid)

Regulatory Jobs; Portage (MI); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Stryker Corporation in Redmond, WA or Portage, MI is seeking a Senior Quality Assurance Engineer to lead field action assessments and investigations that impact patient safety and product performance. You will drive containment, corrective actions, and CAPA across the product lifecycle in a high-impact, regulated environment.

You will collaborate with R&D, Manufacturing, Regulatory, and Quality teams to ensure compliance with ISO 14971, ISO 13485, and post-market requirements.

Qualifications

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

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 defined 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.

Skills

Bachelor’s degree in science/engineer

2+ years QA experience

Regulated industry experience

Post-market QA experience

Education

Bachelor’s degree in science or engineering

Master’s degree in science or engineering

Tools

ISO 14971

ISO 13485

21 CFR Part 820

EU MDR

Job description

Stryker Corporation in Redmond, WA or Portage, MI is seeking a Senior Quality Assurance Engineer to lead field action assessments and investigations that impact patient safety and product performance. You will drive containment, corrective actions, and CAPA across the product lifecycle in a high-impact, regulated environment.

You will collaborate with R&D, Manufacturing, Regulatory, and Quality teams to ensure compliance with ISO 14971, ISO 13485, and post-market requirements.