Senior Engineer, Quality Assurance

Redmond, WA

Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you’ll lead critical investigations and drive improvements that shape the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle.

Work Flexibility:
Hybrid: Candidates must reside within a commutable distance to Redmond, WA, and be able to work onsite several times per week.

What You Will Do

• Lead product field action assessments (PFAA) from initiation through board approval, ensuring timely and thorough execution.
• Investigate customer complaints and non-conformances, determine root causes, and assess health risks to support regulatory compliance.
• Conduct health risk assessments (HRA) and document findings in Trackwise to support post-market surveillance.
• Author and manage non-conformance (NC) and corrective/preventive action (CAPA) records, collaborating with cross-functional teams to define deliverables and timelines.
• Provide statistical analysis and containment recommendations to support quality investigations and decision-making.
• Serve as a subject matter expert in risk management, product safety, and quality assurance processes, mentoring peers and supporting audits.
• Partner with regulatory teams to ensure accurate and timely reporting to competent authorities.
• Drive continuous improvement by strengthening interfaces between pre-market and post-market processes and promoting cohesive risk management strategies.

What You Will Need

Required Qualifications

• Bachelor’s degree in science, engineering, or a related discipline.
• 2+ years of experience in quality assurance or customer quality.
• Demonstrated experience with ISO 14971, ISO 13485, CFR 21 Part 820, and EUMDR.
• Experience conducting post-market quality assessments and product field actions.

Preferred Qualifications

• Master’s degree in a related field.
• Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE).
• Six Sigma Green Belt or Black Belt certification.
• Experience in a regulated industry (e.g., Medical Device, Aerospace)

 $88,800 - $142,300 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Individual pay is based on skills, experience, and other relevant factors.