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Quality Engineer Medical Device Jobs (NOW HIRING)

Cordis

Quality Engineer I - Medical Device

Irvine, CA

$68K - $84K/yr

... device combination products for the treatment of coronary and peripheral artery disease. Our ... Responsibilities The Quality Engineer I will be responsible for ensuring that our medical devices ...

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Fusion Life Sciences Technologies LLC

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Test Engineer Medical Device

Trumbull, CT · On-site

$55 - $58/hr

Ensure compliance with laboratory safety procedures and quality standards. * Collaborate with cross ... or R&D engineering within the medical device or pharmaceutical industry . * Hands-on experience ...

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How much do quality engineer medical device jobs pay per hour?

As of Jul 22, 2026, the average hourly pay for quality engineer medical device in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What does a Quality Engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in the medical device industry, and why are they important?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

What Does a Quality Engineer for Medical Devices Do?

As a quality engineer for medical devices, you oversee the continual improvement of medical devices as well as the design and manufacturing of new devices. Your duties are to develop prototypes, assess the quality of manufacturing standards, and develop guidelines for technological improvement. You also work closely with medical device engineers to ensure sufficient documentation and standardization, which helps users and service technicians test and maintain the safety of devices. Your responsibilities as a medical device quality engineer relate to all aspects of the product life cycle, from prototyping to the supply chain to production.

How does a Quality Engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
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Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in the United States as of July 2026, with employment types broken down into 77% Full Time, 14% Part Time, and 9% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Quality Engineer - Medical Devices

Stark Pharma Solutions Inc

Minneapolis, MN • On-site

$75K - $97K/yr

Contractor

Posted 2 days ago

Job description

Job Title: Quality Assurance Engineer – Medical Devices

Location: Northwest Minneapolis Metro Area

Type: 6-Month Contract-to-Hire

Job Summary

Seeking a Quality Assurance Engineer to support quality systems, manufacturing operations, CAPA, validation, audits, and DHF activities within a medical device environment. This role will partner cross-functionally to ensure compliance with FDA and ISO standards throughout the product lifecycle.

Key Responsibilities

  • Manage CAPAs, nonconformances, root cause investigations, and change controls
  • Support IQ/OQ/PQ validation activities and review quality documentation
  • Maintain DHF documentation and support product lifecycle activities
  • Review batch records, work orders, and manufacturing documentation for GMP compliance
  • Support incoming inspection, supplier quality, and audit readiness
  • Analyze quality metrics and drive continuous improvement initiatives
  • Support customer complaint investigations and PLM system updates

Required Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 5+ years of medical device quality or design assurance experience
  • Strong knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971
  • Experience with CAPA, NCs, DHF, audits, and validation activities
  • Familiarity with PLM systems such as Windchill, Agile, or Propel