Jobs via Dice
Senior Engineer, Quality Assurance
Location: Redmond, WA
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.
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).
Salary range: $88,800 – $142,300 plus bonus eligible, with additional short‑term and long‑term financial incentives. Individual pay is based on skills, experience, and other relevant factors.
Travel: 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.
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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.
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).
Salary range: $88,800 – $142,300 plus bonus eligible, with additional short‑term and long‑term financial incentives. Individual pay is based on skills, experience, and other relevant factors.
Travel: 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.
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