Base: $102,480 to $163,968; bonus/equity: not spec...
On-site (5 days per week)
Process failure mode and effects analysis (pfmea)
Nonconformance event investigations
Corrective and preventive actions (capa)
Philips UK is seeking a Process Quality Engineer to enhance the quality and compliance of manufacturing processes at their Bedford, MA facility. The ideal candidate will have extensive experience in FDA-regulated environments and a strong background in quality operations, process validation, and continuous improvement
Job Summary
The Process Quality Engineer is responsible for facilitating a state of high-quality performance, compliance, and critical oversight/performance monitoring of Philips manufacturing processes, driving compliance and continuous improvement throughout the manufacturing process.
Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
The pay range for this position in Bedford, MA is $102,480 to $163,968.
Matching Summary
Match Score: 85
Philips UK is seeking a Process Quality Engineer to enhance the quality and compliance of manufacturing processes at their Bedford, MA facility. The ideal candidate will have extensive experience in FDA-regulated environments and a strong background in quality operations, process validation, and continuous improvement.
Salary
Base: $102,480 to $163,968; Bonus/Equity: Not specified; Benefits: Generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more
Skills & Requirements
Must-have
Process Failure Mode and Effects Analysis (PFMEA)
Nonconformance event investigations
Corrective and Preventive Actions (CAPA)
Process validation and improvement
New Product Introduction (NPI)
Environmental monitoring programs
Nice-to-have
Supplier Quality Engineering (SQE)
Advanced statistical analysis methods
Cross-functional team leadership
Mentoring less experienced engineers
Key Requirements
5+ years experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing
Experience with ISO 14971
Bachelor’s Degree in Quality, Engineering or similar disciplines