Work Flexibility: Hybrid
Senior Engineer, Quality AssuranceRedmond, 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 NeedRequired 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.
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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