Quality Principal Engineer
About The Position
Quality Principal Engineer In this role you You will lead cross-functional initiatives and Projects, set quality engineering standards, and mentor the next generation of quality and technical engineers and leaders. This is a hands-on role with strategic impact on deep statistical and technical standardization and high-level architectural leadership. Your role: Represent the Quality function as a subject matter expert in Process verification- and validation activities from planning to execution, including Risk management on e.g. PFMEA and PMS activities Represent the Quality function as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices. Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment. Develop strategy for the creation of test- and inspection plans for critical to Quality/Safety acceptance criteria with a risk-based approach related to Product/Part risk. Determine a global standard for Acceptance Quality Level (AQL) based on Product/Part criticality combined with a dynamic approach for incoming inspection test failures
Requirements
- Bachelor's or Master's Degree in Quality Management, Supply Chain Management, Engineering, Operational excellence, Science or equivalent.
- 5+ years of experience as a Quality- Engineer in the medical device or IVD industry supporting the development of complex electro-mechanical devices is required or Master's with 3+ years
- Experience with manufacturing processes, shopfloor management, new product innovation and Project management are required.
- Working knowledge of QSR, CFR21Part820, MDD/EU-MDR, ISO-13485 and ISO-14971 is required.
- Experience in statistical and problem-solving techniques.
- Global experience working with multiple cultures and functions, experience in moderating heterogenous groups towards solutions.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
- US work authorization is a precondition of employment.
- For this position, you must reside in or within commuting distance to Murrysville, PA.
Responsibilities
- Represent the Quality function as a subject matter expert in Process verification- and validation activities from planning to execution, including Risk management on e.g. PFMEA and PMS activities
- Represent the Quality function as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
- Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
- Develop strategy for the creation of test- and inspection plans for critical to Quality/Safety acceptance criteria with a risk-based approach related to Product/Part risk.
- Determine a global standard for Acceptance Quality Level (AQL) based on Product/Part criticality combined with a dynamic approach for incoming inspection test failures
Benefits
- Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
