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Quality Engineer Medical Device Jobs in Michigan

Excel Medical Products

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 ...

Excel Medical Products

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 ...

Excel Medical Products

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 ...

WilsonCTS

Staff Supplier Quality Engineer

Kalamazoo, MI · On-site

$60 - $65/hr

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

Marmon

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 ...

Stryker

Staff Quality Engineer - Service

Kalamazoo, MI · On-site

$89K - $148K/yr

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 ...

Stryker

Staff Quality Engineer - Service

Kalamazoo, MI · On-site

$89K - $148K/yr

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 ...

Kelly Services

Supplier Quality Engineer

Kalamazoo, MI · On-site

$53 - $56/hr

Staff Supplier Quality Engineer * Location: 100% ONSITE - Kalamazoo, Michigan - REMOTE POTENTIAL ... Knowledge and understanding of US and International Medical Device Regulations * Travel required ...

New

Stryker

Senior Quality Engineer

Kalamazoo, MI · On-site

$77K - $129K/yr

Onsite At Stryker, our quality engineers play a critical role in ensuring products consistently ... S. and international medical device regulatory requirements * Experience managing nonconformance ...

Stryker

Senior Quality Engineer

Kalamazoo, MI

$77K - $129K/yr

Onsite At Stryker, our quality engineers play a critical role in ensuring products consistently ... S. and international medical device regulatory requirements * Experience managing nonconformance ...

Hire Quality Strategies

Quality Engineer

Romulus, MI

$69K - $89K/yr

Our company is seeking a skilled Quality Engineer to join our team. We are a Tier II automotive supplier. Following are the job duties: - Conduct quality inspections and analyze product ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Michigan

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, 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.
More about Quality Engineer Medical Device jobs
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:
Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in Michigan as of June 2026, with employment types broken down into 90% Full Time, and 10% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution.

Medical Device Assembly

Excel Medical Products

Wixom, MI • On-site

$16 - $17/hr

Full-time

Medical, Retirement, PTO

Posted 8 days ago

Job description

Benefits:
  • 401(k)
  • Employee discounts
  • Health insurance
  • Paid time off

About the Role:
Excel Medical Products in Wixom, MI is looking for a detail-oriented Medical Device Assembler to join their growing team. This is a great opportunity to be part of a precision-driven environment where your work directly impacts patient care and product quality. If you take pride in accuracy and craftsmanship, we want to hear from you!
Responsibilities:
  • Assemble medical devices and components according to engineering drawings, work instructions, and quality standards
  • Inspect finished assemblies for defects, dimensional accuracy, and compliance with specifications
  • Operate hand tools, fixtures, and assembly equipment in a cleanroom or controlled manufacturing environment
  • Document production activities, lot traceability, and quality records per FDA and ISO regulations
  • Identify and report non-conforming materials or process deviations to supervisors
  • Maintain a clean, organized, and safe workstation in accordance with GMP guidelines
  • Collaborate with quality and production teams to meet daily output and delivery goals
Requirements:
  • High school diploma or GED required
  • Prior experience in medical device assembly, electronics assembly, or precision manufacturing preferred
  • Ability to read and follow work instructions, BOMs, and technical drawings
  • Strong attention to detail and manual dexterity for fine assembly work
  • Familiarity with GMP, ISO 13485, or FDA quality system regulations is a plus
  • Ability to stand, sit, and perform repetitive tasks throughout an 8-hour shift
  • Reliable, punctual, and able to work effectively in a team-oriented environment
About Us:
Excel Medical Products is a trusted name in the medical device manufacturing industry, proudly serving healthcare professionals and patients from our facility in Wixom, MI. Our commitment to precision, quality, and innovation has earned us a reputation for excellence among our customers and partners. We foster a supportive workplace culture where employees are valued, trained, and empowered to grow their careers in the medical manufacturing field.