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Quality Assurance Engineering Manager
Quality Assurance Engineering ManagerStryker • Redmond, WA, US
Quality Assurance Engineering Manager

Quality Assurance Engineering Manager

Stryker • Redmond, WA, US
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Quality Assurance Engineering Manager

Join a team where your expertise directly impacts patient safety and product excellence. As a Quality Assurance Engineering Manager in our Emergency Care division, you'll drive critical quality initiatives that shape how life-saving medical devices are assessed, sustained, and improved. This is a high-impact role for someone energized by innovation, precision, and leadership in the medical technology space.

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

  • Establish a Quality Assurance Center of Excellence to drive consistency and excellence across post-market processes.
  • Provide guidance for product field action assessments, non conformance and corrective / preventive actions, and ensure execution aligns with key performance indicators (KPIs) and regulatory expectations.
  • Review and approve critical documentation including regulatory communications and customer-facing materials to ensure completeness and accuracy.
  • Implement automated quality control methods to reduce errors and improve process efficiency.
  • Partner with cross-functional teams to integrate pre-market and post-market risk management strategies.
  • Serve as a subject matter expert during internal and external audits, including interactions with health authorities.
  • Recruit, develop, and manage high-performing team members, fostering engagement and accountability.
  • Define and monitor performance objectives and KPIs to ensure continuous improvement and operational excellence.

What You Will Need

Required Qualifications

  • Bachelor's degree in Engineering, Science, or a related field
  • 8+ years of experience in quality assurance or customer quality
  • Demonstrated experience managing post-market quality processes and product field actions
  • Experience leading and developing teams.
  • Demonstrated experience in Risk Management / Product Safety (ISO 14971)
  • Experience supporting internal and external audits and regulatory inspections
  • Preferred Qualifications

  • Master's degree in Engineering or Quality-related discipline
  • Certified Quality Engineer (CQE)
  • Lean Six Sigma or Six Sigma Black Belt certification
  • Experience in a regulated industry (e.g., Medical Device, Aerospace)
  • $132,900 - $217,500 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.

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    Quality Assurance Manager • Redmond, WA, US

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