Philips Quality Engineer 

United States, Minnesota 

557765702

Your role:

• Primary quality support for integrations and ongoing support of sustaining activities, including evaluation of change notifications internally and externally, quality issues, and identification of improvement opportunities.

• Lead complaint investigations and returned product evaluations. Write and coordinate efforts for the development and implementation of new and updated Quality System procedures.

• Lead the non-conforming material process and the Materials Review Board, including CAPA, SCARs, Complaints, Equipment Events, and OOS. Lead problem -solving teams through root cause investigations and failure analysis to implementation and final verification.

• Ensure Risk Management is effective utilizing feedback from validation, post market surveillance, manufacturing indicators, NCR’s, CAPAs, IIAs, etc.

• Provide Subject Matter Expertise (SME) and mentoring in all Quality System Elements, with particular strength in Design and Production Process controls and Test Method Validations.

You're the right fit if:

• You’ve acquired 5+ years of experience in the medical device industry.

• Your skills include experience with FDA requirements 21 CFR 820, the knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements. Experience with Class III permanent implantable medical devices is highly preferred, proficiency with statistical software package (Minitab) and Certified Six Sigma Belt is a plus

• You have a Bachelor’s in Engineering, life science or related field or equivalent years of experience

• You have excellent communication skills while collaborating with cross functional teams such as R&D, Product Development, Supplier Quality, Operations, and Quality Systems.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together

This is an in office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in Minnesota is $83,790 to $143,640

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

within commuting distance to Plymouth, MN.