Philips Quality Engineer 

United States, Minnesota 

523901196

Quality Engineer I
Job Description

The Quality Engineer I is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.

Your role:

• Provide quality support for sustaining activities and new product introductions, including evaluating internal and external change notifications, addressing quality issues, and identifying improvement opportunities. Develop and execute Test Methods for incoming inspection and in process manufacturing.

• Assist with complaint investigations and returned product evaluations, ensuring accurate documentation and follow-up actions. Support the non-conforming material process, including documentation, investigation, and resolution of non-conformances (NCRs).

• Participate in root cause investigations and failure analysis, contributing to corrective and preventive action (CAPA) efforts. Assist with Risk Management activities by incorporating feedback from post-market surveillance, validation, manufacturing indicators, NCRs, and CAPAs.

• Collaborate with cross-functional teams, including Manufacturing Engineering, Operations, and Supplier Quality, to ensure compliance with quality system requirements.

You're the right fit if:

• You’ve acquired 2+ years of experience in engineering, preferably in the medical device industry.

• Your skills include familiarity with FDA regulations (21 CFR 820), ISO 13485, and GMP requirements. Experience with test method validations and failure investigations is a plus. Experience with statistical tools (Minitab) or Six Sigma methodologies are a plus but not required.

• You have a bachelor’s degree in an engineering discipline, or a related field.

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

• You’re an individual with strong analytical and problem-solving skills, attention to detail in investigations and documentation is essential. You have effective communication and collaboration skills, working with cross functional teams to drive quality improvements.

How we work together

This is an 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 $63,788 to $102,060

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.