Senior Quality Assurance Engineer - Medical Devices (Hybrid)

Stryker Corporation (old); Redmond (WA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Stryker Corporation in Redmond, WA is seeking a Senior Quality Assurance Engineer to lead Emergency Care investigations and drive post-market improvements across the product lifecycle. The role supports a hybrid work model with onsite presence several times per week, serving Redmond, WA or Portage, MI.

Responsibilities include containment actions, CAPA management, cross‑functional collaboration, audits, and ensuring timely, compliant documentation while upholding risk management standards across

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 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 documentation.
• Investigate complex product quality issues using structured problem-solving and root cause analysis.
• Perform post-market health risk assessments and health hazard evaluations for patient safety.
• Develop containment recommendations and corrective actions based on findings and quality data.
• Author and manage nonconformance and CAPA records with defined deliverables and timelines.
• Coordinate investigations and corrective action reviews with R&D, Manufacturing, Regulatory, Quality, Marketing, Service and suppliers.
• Represent QA processes during audits and maintain compliance with quality systems and risk management requirements.

Skills

Quality assurance

Root cause analysis

Regulatory understanding

Post-market quality assessments

Education

Bachelor's degree in science, engineering, or a related discipline

Master’s degree in science, engineering, or related discipline

Six Sigma Green Belt certification

Job description

Stryker Corporation in Redmond, WA is seeking a Senior Quality Assurance Engineer to lead Emergency Care investigations and drive post-market improvements across the product lifecycle. The role supports a hybrid work model with onsite presence several times per week, serving Redmond, WA or Portage, MI.

Responsibilities include containment actions, CAPA management, cross‑functional collaboration, audits, and ensuring timely, compliant documentation while upholding risk management standards across