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Quality Engineering Manager Medical Device Jobs

Halo Industries, Inc.

$195K - $215K/yr

The Opportunity As the Quality Engineering Manager, you will execute and champion Halo's production ... Health Care Plan (Medical, Dental & Vision) * Retirement Plan (401k, IRA) * Paid Time Off (Vacation ...

Stryker

Associate Manager, Quality Engineering

Portage, MI · On-site

$110K - $183K/yr

Hybrid Join Stryker's Emergency Care business as an Associate Manager, Quality Engineering in ... S. and international medical device regulations and standards, including 21 CFR Part 820, ISO 13485 ...

nLIGHT

Supplier Quality Engineering Manager

Camas, WA · On-site

$90K - $120K/yr

Position Summary The Supplier Quality Engineering Manager leads a team responsible for ensuring ... Medical, Dental and Vision Benefits, including prescription and orthodontia with employee-paid ...

nLIGHT

Supplier Quality Engineering Manager

Camas, WA · On-site

$90K - $120K/yr

Position Summary The Supplier Quality Engineering Manager leads a team responsible for ensuring ... Medical, Dental and Vision Benefits, including prescription and orthodontia with employee-paid ...

Versa Vascular

Working knowledge of FDA medical device regulations and ISO 13485. * Experience with supplier ... Experience with Design Controls, risk management, verification and validation, and design transfer.

nLIGHT

Supplier Quality Engineering Manager

Camas, WA · On-site

$90K - $120K/yr

Position Summary The Supplier Quality Engineering Manager leads a team responsible for ensuring ... Medical, Dental and Vision Benefits, including prescription and orthodontia with employee-paid ...

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Quality Engineering Manager Medical Device information

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$60K

$111.7K

$158.5K

How much do quality engineering manager medical device jobs pay per year?

As of Sep 10, 2026, the average yearly pay for quality engineering manager medical device in the United States is $111,650.00, according to ZipRecruiter salary data. Most workers in this role earn between $92,000.00 and $131,000.00 per year, depending on experience, location, and employer.

What does a quality engineering manager do in the medical device industry?

A Quality Engineering Manager in the medical device industry oversees the quality assurance and control processes to ensure products meet regulatory standards and customer expectations. They lead teams responsible for implementing quality systems, conducting audits, and resolving quality issues. Their role often includes ensuring compliance with standards such as ISO 13485 and FDA regulations, managing risk assessments, and driving continuous improvement initiatives. They also collaborate with other departments to support product development and manufacturing while maintaining product safety and effectiveness.

What are the key skills and qualifications needed to thrive as a quality engineering manager in the medical device industry?

To thrive as a Quality Engineering Manager in medical devices, you need a strong background in quality assurance, regulatory compliance (like FDA and ISO 13485), and a degree in engineering or a related field. Familiarity with quality management systems (QMS), risk management tools (such as FMEA), and certifications like Six Sigma or ASQ are typically required. Leadership, problem-solving, and effective communication are vital soft skills for managing teams and driving continuous improvement. These competencies ensure product safety, regulatory adherence, and high-quality outcomes critical to patient health and company success.

What are some common challenges faced by a quality engineering manager in the medical device industry, and how can they be addressed?

A Quality Engineering Manager in the medical device field often faces challenges such as navigating complex regulatory requirements, ensuring cross-functional teams adhere to quality standards, and managing product risk throughout the development lifecycle. Staying current with evolving regulations (like FDA and ISO 13485) and fostering a culture of continuous improvement are key to overcoming these hurdles. Effective communication and collaboration with engineering, manufacturing, and regulatory teams help ensure all processes align with compliance and quality objectives, ultimately supporting safe and successful product launches.

What are popular job titles related to Quality Engineering Manager Medical Device jobs?

For Quality Engineering Manager Medical Device jobs, the most frequently searched job titles are:

Infographic showing various Quality Engineering Manager Medical Device job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $111,650 per year, or $53.7 per hour.

Senior Design Assurance Engineer - Medical Device (Onsite - Arbor Lakes, MN) Contract

Maple Grove, MN • On-site

Pharmavise
IT Services • 11 - 50 employees
Learn more about Pharmaviseexternal

Full-time

Re-posted 2 days ago

Job description


Job Role: Senior Design Assurance Engineer - Medical Device (Onsite - Arbor Lakes, MN) Contract
Overview:
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp
Our F500 Medical Device client has an exciting opportunity for a Senior Design Assurance Engineer.
Job Summary:
The Sr Design Assurance Engineer provides focused quality engineering leadership on sustaining design assurance activities. Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for supporting risk document and post market record review during remediation activities as well as ensuring quality and compliance through post commercialization sustaining activities.
Requirements
Required Qualifications
  • Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline

  • 5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience

  • Understanding of electrical safety standards IEC 60601

  • Experience with reliability testing

  • Demonstrated use of Quality tools/methodologies

  • Strong written/verbal communication skills.

  • Risk documentation per ISO14971

Preferred Qualifications:
  • Experience with class III medical devices
  • BS in Electrical Engineering
  • Previous R&D experience
  • Strong knowledge of QSR and ISO standards
  • Medical device experience
  • ASQ certification

Apply