Senior Quality Engineer

Philips; Plymouth (MN); On-site; USD 88,000 - 142,000; Full time

Job summary

Philips is seeking a Senior Quality Engineer to ensure the quality and compliance of life-saving medical devices. This role involves leading investigations, driving continuous improvement, and collaborating with cross-functional teams. Candidates should have extensive experience in the medical device industry, particularly with FDA regulations and quality systems.

Benefits

Generous PTO

401k with up to 7% match

HSA with company contribution

Stock purchase plan

Education reimbursement

Qualifications

• 5+ years of experience in the medical device or regulated industry.
• Experience with class III permanent implantable medical devices.
• Proficiency in statistical software like Minitab.

Responsibilities

• Lead investigations and drive continuous improvement in quality systems.
• Manage the Nonconforming Material process and lead cross-functional teams.
• Ensure effective risk management activities throughout the product lifecycle.

Skills

FDA requirements 21 CFR 820

GMP

ISO 13485

Statistical software proficiency

Education

Bachelor of Science degree in engineering or life sciences

Job description

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As a Senior Quality Engineer, you will play a critical role in ensuring the quality and compliance of life-saving medical devices by leading investigations, driving continuous improvement, and strengthening the quality system. You’ll collaborate closely with cross-functional teams including Manufacturing, Research and Development, Regulatory, and Supplier Quality, serving as a key voice in sustaining product quality. This role offers the opportunity to deepen expertise in risk management, test method validation, and regulatory compliance, with potential for cross-site collaboration and occasional travel, all while contributing to a high-impact, patient-focused mission.

Your role:

• Serve as the primary Quality representative for sustaining activities, including assessment of change notifications, support for design modifications to released products, resolution of quality issues, and identification of continuous improvement opportunities.
• Author, revise, and coordinate the implementation of Quality System procedures to ensure ongoing compliance with regulatory and internal requirements.
• Manage the Nonconforming Material process and lead the Materials Review Board (MRB); support related quality system activities including CAPAs (corrective and preventative action), SCARs (supplier corrective action request), complaints, equipment events, and out-of-specification (OOS) findings. Facilitate and lead cross-functional teams in structured problem-solving efforts, from root cause analysis to implementation and verification of corrective actions.
• Ensure risk management activities remain effective throughout the product lifecycle by leveraging data from validations, post-market surveillance, manufacturing trends, CAPAs, NCRs (nonconformance report), and internal investigations.
• Act as a Subject Matter Expert (SME) and mentor in Quality System elements, with particular expertise in design and production process controls, and test method validation (TMV).

You're the right fit if:

• You’ve acquired 5+ years of experience in the medical device or other regulated industry.
• Your skills include experience with FDA requirements 21 CFR 820, knowledge of regulations such as GMP, ISO 13485 and other international regulatory requirements as well as experience with class III permanent implantable medical devices or combination product.
• You have a Bachelor of Science degree in engineering, life sciences, or another 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 a go-getter with proficiency in a statistical software package (such as Minitab).

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.

The pay range for this position in Minnesota is $88,200 to $141,120 annually.

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, Minnesota USA.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Medical Equipment Manufacturing

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