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