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Quality Engineer Medical Device Jobs in Michigan

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... and Class II medical device design controls. * Help stand up engineering processes and ... Support buildout of a Quality Management System (QMS) in anticipation of future ISO 13485 ...

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

... engineering drawings, work instructions, and quality standards * Inspect finished assemblies for ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

  • Medical

  • Retirement

  • PTO

... engineering drawings, work instructions, and quality standards * Inspect finished assemblies for ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

... engineering drawings, work instructions, and quality standards * Inspect finished assemblies for ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Hybrid Staff Advanced Quality Engineer Portage, MI Join a team focused on advancing quality throughout the product development lifecycle in a regulated medical device environment. As a Staff Advanced ...

New

Quality Engineer

Clinton, MI · On-site

$71K - $91K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Acts as the primary advocate for compliance and Quality Assurance Engineering of medical devices and medical device components for the development of Validation programs and program compliance ...

Staff Engineer, Supplier Quality Engineering Employment Type: 18-month contract Work Location ... Ensure supplier quality activities align with applicable medical device, regulatory, and quality ...

As the Staff Quality Engineer - Service you will focus on developing and standardizing inspection ... Experience in medical device development or manufacturing. * Knowledge of FDA 21 CFR Part 820, ISO ...

As the Staff Quality Engineer - Service you will focus on developing and standardizing inspection ... Experience in medical device development or manufacturing. * Knowledge of FDA 21 CFR Part 820, ISO ...

Quality Engineer

Sault Sainte Marie, MI · On-site

$68K - $88K/yr

Quality Engineer must have very good attention to detail and full understanding of the ... Medical Device Standard Responsibility/Authority Participate in Material Review Board (MRB ...

Sr. Quality Engineer

Marquette, MI · On-site

$69K - $90K/yr

Quality Engineer - Quality Control (QC QE)Position Summary The Quality Engineer - Quality Control ... Medical device or other regulated manufacturing experience preferred. * Knowledge of ISO 13485 and ...

Quality Engineer

Clinton Township, MI

$66K - $86K/yr

Acts as the primary advocate for compliance and Quality Assurance Engineering of medical devices and medical device components for the development of Validation programs and program compliance ...

Quality Engineer

Grand Rapids, MI · On-site

$69K - $89K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

POSITION SUMMARY The Quality Engineer position is focused on ensuring product quality and ... Exposure to the FDA, medical device or medical manufacturing is a strong plus. * Experience in ...

Quality Engineer

Grand Rapids, MI · On-site

$69K - $89K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

POSITION SUMMARY The Quality Engineer position is focused on ensuring product quality and ... Exposure to the FDA, medical device or medical manufacturing is a strong plus. * Experience in ...

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Quality Engineer Medical Device information

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?

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.

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.

What are the most commonly searched types of Quality Engineer Medical Device jobs in Michigan?

The most popular types of Quality Engineer Medical Device jobs in Michigan are:

What are popular job titles related to Quality Engineer Medical Device jobs in Michigan?

For Quality Engineer Medical Device jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Quality Engineer Medical Device jobs in Michigan look for?

The top searched job categories for Quality Engineer Medical Device jobs in Michigan are:

Infographic showing various Quality Engineer Medical Device job openings in Michigan as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, 1% Temporary, and 6% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

System Development Engineer- Medical Device

Tek Labs Inc

Zeeland, MI • On-site

Other

Posted 6 days ago


Job description

Title: System Development Engineer- Medical Device
Location: Zeeland, MI (Onsite)
Duration: Long-Term Contract

Key Requirements:

  • Bachelor’s degree in Electrical Engineering, Computer Engineering, Software Engineering, or a related field with 5–10 years of Systems Engineering experience.
  • Experience developing system requirements, system architecture, interface requirements, and end-to-end requirements traceability.
  • Hands-on experience with system validation, System FMEA, and systems engineering processes.
  • Strong knowledge of ISO 26262 (ASIL), ASPICE, and embedded software/system development.

This role involves leading system-level development for cabin monitoring, digital vision, connectivity, and other advanced automotive technologies, including system architecture, requirements management, traceability, and system validation.