Senior Design Quality Engineer
$92,000–$146,000 year
On-site · Murrysville, Pennsylvania, United States
Job Summary
Senior Design Quality Engineer responsible for ensuring that quality plans are developed across the product lifecycle for Philips Sleep & Respiratory Care hardware, providing oversight of design input, design V&V, design transfer and product realization, and monitoring design performance in the field to meet design requirements. Includes post-market data analysis, CAPA initiation when required, and analytics to support business decisions on design and realization processes.
Required Qualifications
- Minimum of 5+ years’ experience in FDA regulated medical device environments, focusing on Design Assurance/Control and strong understanding of ISO 13485 / 9001 / FDA / Canada
- Bachelor’s Degree in Quality, Engineering or similar disciplines (Required)
- Experience with Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, Root Cause analysis and Defect Management
- Experience identifying and supporting processes and design quality tools for tracking/preventing product defects, design traceability, and Design for Reliability
- Experience using Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement across product lifecycle
- Able to share knowledge on quality standards and regulatory requirements
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