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Quality Engineer Medical Device Jobs in Michigan

Exalta Group

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 ...

TriMas Corporation

Quality Engineer

Clinton Township, MI · On-site

$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 ...

Stryker Group

Senior Quality Engineer

Kalamazoo, MI · On-site

$77.70 - $129.50/hr

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

AirLife

Quality Engineer

Grand Rapids, MI · On-site

$69K - $89K/yr

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 ...

AirLife

Quality Engineer

Grand Rapids, MI · On-site

$69K - $89K/yr

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 ...

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 · 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 ...

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 ...

Three Point Solutions

Medical Assembler

Grand Rapids, MI · On-site

$18 - $20/hr

Assemble medical device components. * Build electronic and mechanical assemblies. * Follow diagrams and work instructions. * Use hand and power tools. * Perform quality inspections. * Conduct ...

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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 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 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.

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 August 2026, with employment types broken down into 1% As Needed, 73% Full Time, 16% Part Time, 2% Temporary, 7% Contract, and 1% Nights. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Sr. Quality Engineer

Exalta Group

Marquette, MI • On-site

$69K - $90K/yr

Full-time

Re-posted 5 days ago

Key responsibilities

  • Lead and support Measurement System Analysis (MSA), Gauge R&R, correlation studies, and inspection/test method qualification.

  • Evaluate and determine appropriate inspection methods and equipment to ensure measurement capability and product conformity.

  • Review inspection plans, analyze measurement data, and support standardization and optimization of inspection practices across sites.

Job description

Quality Engineer – Quality Control (QC QE)Position Summary

The Quality Engineer – Quality Control (QC QE) provides technical Quality Engineering support to ensure inspection and measurement activities are capable, appropriate, and consistently applied across manufacturing sites.

This role will focus heavily on measurement system capability, inspection method selection, Gauge R&R/MSA, correlation of inspection methods across sites, and standardization of Quality Control practices. The QC QE will work closely with Quality, Engineering, Metrology, and Operations to ensure the right measurement method is being used for each product characteristic and that inspection systems are capable of reliably determining product conformity.

Key Responsibilities
  • Lead and support Measurement System Analysis (MSA), Gauge R&R, correlation studies, and inspection/test method qualification.
  • Evaluate CMMs, vision systems, custom gauges, hand tools, fixtures, and other measurement methods to ensure they are appropriate and capable for the characteristics being inspected.
  • Determine the most appropriate inspection methodology based on tolerance, feature complexity, measurement capability, risk, and manufacturing process.
  • Identify situations where existing inspection methods are inadequate, overly complex, inefficient, or introduce unnecessary measurement variation.
  • Drive alignment of inspection methods across sites to ensure the same characteristics are measured using technically equivalent and reproducible methods.
  • Investigate discrepancies in measurement results between sites, equipment, programs, inspectors, suppliers, and customers.
  • Partner with Engineering and Metrology to develop and qualify new inspection methods where needed.
  • Review inspection plans and requirements to ensure inspection methods, equipment, sampling, and acceptance criteria are technically appropriate.
  • Analyze inspection and measurement data to identify recurring issues, measurement variation, process drift, and opportunities for improvement.
  • Support development of standardized inspection instructions and measurement practices across the organization.
  • Provide technical coaching to inspectors on measurement techniques, drawing interpretation, GD&T, and appropriate use of inspection equipment.
  • Support new product introductions and product transfers by ensuring inspection methods, equipment, programs, MSA, and documentation are established prior to implementation.
  • Identify opportunities to optimize inspection based on demonstrated measurement capability, process performance, historical data, and risk.
  • Prepare technical and statistical justification for proposed inspection strategy changes for Quality Assurance review and approval.
Decision Authority

The QC QE may recommend changes to inspection methods, measurement equipment, sampling strategies, and inspection frequency based on technical and statistical analysis.

Final approval for changes to established inspection requirements or inspection reductions remains with Quality Assurance.

Qualifications
  • Bachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline; equivalent technical experience may be considered.
  • 5+ years of Quality Engineering, Metrology, Quality Control, or precision-manufacturing experience.
  • Strong experience with MSA and Gauge R&R.
  • Experience with CMM, vision systems, hand measurement tools, and custom gauges.
  • Strong understanding of engineering drawings, tolerances, and GD&T.
  • Experience with statistical analysis and data-driven problem solving.
  • Experience developing or qualifying inspection and measurement methods.
  • Medical device or other regulated manufacturing experience preferred.
  • Knowledge of ISO 13485 and applicable FDA requirements preferred.
Key Measures of Success
  • Capable and appropriately qualified measurement systems.
  • Strong MSA and Gauge R&R performance.
  • Consistent inspection methodologies across manufacturing sites.
  • Reduction in measurement discrepancies between sites.
  • Improved selection of inspection equipment and methods.
  • Standardized QC practices and inspection instructions.
  • Reduced inspection inefficiency without compromising product quality.
  • Reliable inspection data that supports sound Quality decisions.

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