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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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.