Quality Engineer

Job TitleQuality Engineer

Job Description

The Quality Engineer will serve a critical role in completing both sustaining and integration efforts relevant to disposable medical device activities on new Image Guided Therapy Device product acquisition, ensuring overall project and business objectives.
 

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 position.

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 in 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 commitment to diversity and inclusion.

Philips Transparency Details

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

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.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN.

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.