Senior Engineer, Quality Assurance

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. Apply tot his job