Senior QA Engineer – Medical Device Quality (Hybrid)

Stryker; Portage (MI); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Stryker in Redmond, WA or Portage, MI seeks a Senior Quality Assurance Engineer to lead investigations and ensure patient safety across the product lifecycle. Hybrid work requires commuting to site several times weekly.

You'll own field action assessments, perform root cause analysis, manage CAPAs, and coordinate QA activities with multi-functional teams to uphold compliance and quality standards in a regulated industry.

Qualifications

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

Responsibilities

• Lead product field action assessments from initiation through review and approval with complete documentation.
• Investigate complex product quality issues using structured problem-solving and statistical methods.
• Perform post-market health risk assessments and health hazard evaluations for safety risks.
• Develop containment recommendations and corrective actions based on investigations and data.
• Author and manage nonconformance and CAPA records with defined deliverables and timelines.
• Coordinate investigation and corrective action reviews with cross-functional teams.
• Represent QA processes during audits and ensure compliance with quality systems and regulations.

Skills

Quality assurance

Root cause analysis

Investigations

Statistical evaluation

Audits

Post-market quality

Education

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Tools

ISO 14971

ISO 13485

21 CFR Part 820

Job description

Stryker in Redmond, WA or Portage, MI seeks a Senior Quality Assurance Engineer to lead investigations and ensure patient safety across the product lifecycle. Hybrid work requires commuting to site several times weekly.

You'll own field action assessments, perform root cause analysis, manage CAPAs, and coordinate QA activities with multi-functional teams to uphold compliance and quality standards in a regulated industry.