Senior Quality Assurance Engineer

Join Stryker’s Peripheral Vascular business as a Senior Quality Assurance Engineer and make a direct impact on the performance and safety of commercially released medical devices. Based in Irvine, CA, you’ll play a key role in sustaining engineering efforts that drive product quality, strengthen risk management, and ultimately improve outcomes for patients around the world.

What You Will Do:

• Partner with cross-functional teams to support quality engineering activities for sustaining projects, ensuring commercial products continue to meet safety, performance, and regulatory expectations.

• Execute product safety risk management activities, including health risk assessments for distributed products.

• Develop, review, and approve validation strategies, plans, protocols, and reports in accordance with internal procedures and regulatory requirements.

• Evaluate and enhance test plans, methods, and sampling strategies to maintain compliance and improve product reliability.

• Monitor and analyze post‑market and field performance data; identify trends and recommend corrective or preventive actions to drive continuous improvement.

• Investigate quality issues and contribute to activities related to corrective and preventive actions, nonconformance management, and risk mitigation.

• Participate in internal and external audits, providing technical input related to risk management, CAPA, and sustaining quality activities.

• Contribute to initiatives that improve quality systems, processes, and tools across the organization.

• Serve as a technical resource and share knowledge within the Quality organization.

What You Need:

Required:

• Bachelor’s degree in Engineering, Science, or a related technical discipline.

• Minimum 2+ years of experience in a highly regulated environment (e.g., medical device, pharmaceutical, biotechnology, or similarly regulated industry).

Preferred:

• Advanced degree in Engineering, Science, or a related technical discipline.

• Experience supporting post‑market surveillance or field performance monitoring.

• Certification such as CQE, CQA, or equivalent

$89,400.00 - $148,900 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.