Job Title

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 position.

• 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

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

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.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Minnesota $63,788 to $102,060

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.