Senior Design Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Senior Design Quality Engineer to join our team at Philips North America. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met throughout the product life cycle.
Key Responsibilities- Provide independent oversight of the design input process, design V&V activities, design transfer, and product realization to ensure all design requirements are effectively met.
- Act as a single point of contact responsible for ensuring hardware design meets quality and compliance standards for every milestone.
- Perform independent technical assessments on product quality performance and post-market product quality analysis.
- 4-year degree in a science or engineering discipline and 5+ years of experience.
- 2+ years of experience in product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment with Medical Device experience.
- Experience with FMEAs and Product Safety Risk Management.
- Expertise in Application of Risk Management to Medical Devices (IEC 14971), Medical Device Software Life Cycle Processes (IEC 62304), and Application of Usability Engineering to Medical Devices (IEC 62366), 21CFR820 are pluses.
We offer a comprehensive compensation package, including a competitive salary range of $75,000 to $135,000, annually, and a range of benefits, including a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement, and more.
At Philips, we believe that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Join us in our mission to improve the lives of others.
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