Senior Quality Assurance Engineer
About The Position
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.
Requirements
- 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).
Nice To Haves
- 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
Responsibilities
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
