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Quality Engineer Medical Device Jobs (NOW HIRING)

Talentry, LLC

Be Seen First

Sr. Mechanical Engineer - Medical Device

San Diego, CA · On-site

$130K - $180K/yr

Senior Mechanical Engineer - Medical Device San Diego, CA (Onsite) 130,000-180,000 DOE Join a ... You'll work closely with systems, electrical, quality, regulatory, operations, and lab teams to ...

Saxon Global

QA ENGINEER

Saint Augustine, FL

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

Stark Pharma Solutions Inc

Quality Engineer

Cambridge, MA · On-site

$78K - $101K/yr

Medical Device / Pharmaceutical Job Summary We are seeking a highly motivated and detail-oriented Quality Engineer to support quality assurance and compliance activities within a GMP-regulated ...

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Quality Engineer Medical Device information

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

As of Aug 10, 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?

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.
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What cities are hiring for Quality Engineer Medical Device jobs? Cities with the most Quality Engineer Medical Device job openings:
What are the most commonly searched types of Quality Engineer Medical Device jobs? The most popular types of Quality Engineer Medical Device jobs are:
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What job categories do people searching Quality Engineer Medical Device jobs look for? The top searched job categories for Quality Engineer Medical Device jobs are:
Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, and 9% Contract. Highlights an 100% In-person job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Senior Quality Engineer- Medical Device MFg

TekWissen

Warsaw, IN

$85K - $115K/yr

Full-time

Re-posted 29 days ago

Job description

Company Description

TekWissen provides a unique portfolio of innovative capabilities that seamlessly combines clients insights, strategy, design, software engineering, and systems integration.

www.tekwissen.com 

Job Description

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities.

Qualifications

B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE) plus 3-5 years experience in a Quality Engineering role, or an equivalent combination of education and experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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About TekWissen

Sourced by ZipRecruiter

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Industry

Recruiting and staffing services

Company size

501 - 1,000 Employees

Headquarters location

Ann Arbor, MI, US

Year founded

2009

Social media

Twitter

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