Quality Assurance Engineering Manager

Posted 18 Days Ago
Be an Early Applicant
Redmond, WA
In-Office
133K-218K Annually
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Lead quality assurance initiatives in the Emergency Care division, ensuring compliance with regulations and enhancing product quality in medical devices.
Summary Generated by Built In
Work Flexibility: Hybrid or Onsite

Quality Assurance Engineering Manager
Redmond, WA

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.

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.

Top Skills

Iso 14971
Lean Six Sigma
Six Sigma
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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