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Quality Engineer Medical Device Jobs in Michigan

Hire Quality Strategies

Quality Engineer

Romulus, MI · On-site

$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 ...

Tekhawks LLC

Product Safety Engineer

Kalamazoo, MI · On-site

Experience supporting medical device development in a regulated environment. * Experience developing product safety documentation, compliance strategies, and engineering test plans. * Working ...

Tekhawks LLC

Product Safety Engineer

Kalamazoo, MI · On-site

Experience supporting medical device development in a regulated environment. * Experience developing product safety documentation, compliance strategies, and engineering test plans. * Working ...

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Quality Engineer

Saint Clair Shores, MI · On-site

$85K - $110K/yr

Quality Engineer Quality Engineer has overall responsibility to ensure new products are launched with adequate controls in place. They will establish product quality controls , process controls , and ...

All Engineering Recruitment Solutions

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Quality Engineer

Southfield, MI · On-site

$85K - $110K/yr

Quality Engineer Quality Engineer has overall responsibility to ensure new products are launched with adequate controls in place. They will establish product quality controls , process controls , and ...

All Engineering Recruitment Solutions

Be Seen First

Quality Engineer

Warren, MI · On-site

$85K - $110K/yr

Quality Engineer Quality Engineer has overall responsibility to ensure new products are launched with adequate controls in place. They will establish product quality controls , process controls , and ...

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 ...

Drive

Quality Engineer

Manchester, MI · On-site

$66K - $85K/yr

As a Quality Engineer, you will play a key role in ensuring that our products meet the highest standards of quality and reliability. Responsibilities: * Collaborate with cross-functional teams to ...

Three Point Solutions

Medical Assembler

Dexter, MI · On-site

$18 - $22/hr

Medical Device Manufacturing Company Duration: 12-Month Contract Location: Dexter, MI 48130 Shift ... Perform continuity checks, basic testing, and quality inspections. * Rework, modify, disassemble ...

Actalent

Quality Engineer

Livonia, MI

$67K - $87K/yr

Quality Engineer, midnight shift The Quality Engineer II plays a key role in driving continuous ... Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre ...

Kratos Defense

Quality Engineer

Auburn Hills, MI · On-site

$68K - $88K/yr

The Quality Engineer is responsible for supporting product and process quality across Engineering, Manufacturing, Test, Supply Chain, and Program execution at Technical Directions Inc. This role ...

Actalent

Quality Engineer

Livonia, MI · On-site

$67K - $87K/yr

Job Title: Quality Engineer The Quality Engineer II plays a key role in driving continuous ... Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre ...

Three Point Solutions, Inc.

Medical Assembler

Dexter, MI · On-site

$17.25 - $21/hr

Medical Device Manufacturing Company Duration: 12-Month Contract Location: Dexter, MI 48130 Shift ... Perform continuity checks, basic testing, and quality inspections. * Rework, modify, disassemble ...

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Showing results 21-40

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?

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.
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 92% Full Time, and 8% Contract. Highlights an 100% In-person job distribution.

Quality Engineer

Hire Quality Strategies

Romulus, MI • On-site

$69K - $89K/yr

Other

Posted 21 days ago

Job description

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 specifications
- Implement and maintain ISO 9001 standards
- Oversee quality control processes to identify defects and implement corrective actions
- Knowledge in various production processes such as die casting, forging, stamping, and plastic injection molding, etc

- Proficiency in completing 8D and 5W
- Develop and implement quality assurance procedures
- Collaborate with production teams to fabricate solutions for quality issues

- Assist with new project development like print interpretation, design review meeting with customers

Requirements

- Proven experience in quality engineering roles in auto industry

- Strong knowledge of Quality systems, QA/QC methodologies, and best practices

- Familiarity with ISO 9001 standards and other quality management systems

- Excellent analytical skills with the ability to interpret data and make recommendations for improvement

- Strong communication skills to work effectively with cross-functional teams

- Travels are required as needed

- Fluency in Mandarin Chinese (preferred)

Working Hours: 10am to 5pm, Monday to Friday (1-hour unpaid lunch break from 12pm to 1pm)

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