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Quality Engineer Medical Device Jobs in Indiana (NOW HIRING)

Zimmer Biomet

Quality Engineer I

Warsaw, IN · On-site

$60K - $78K/yr

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred Travel Expectations * Up to 20% EOE #J-18808-Ljbffr

New

VOLT

Medical Device Assembler

Westfield, IN · On-site

$20 - $23/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

Flotec

Be Seen First

Machinist / Inspector - Medical Device Manufacturing

Avon, IN · On-site

$40K - $55K/yr

Machinist / Inspector - Medical Device Manufacturing Company Overview Flotec is an Indianapolis ... Work with production, quality, and engineering personnel to resolve machining or inspection issues.

Zimmer, Inc.

Senior Quality Engineer

Warsaw, IN · On-site

$89K - $112K/yr

Medical device strongly preferred, or an equivalent combination of education and experience. * You have certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE ...

360 IT Professionals

Quality Engineer

Warsaw, IN · On-site

$69K - $89K/yr

CQE). o Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred. o Bachelors degree in sciences, health care certificates, mechanical or biologic ...

CTE Solutions

Supplier Quality Engineer

Plymouth, IN · On-site

Collaborate with internal Quality and Engineering teams to determine appropriate validation ... Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Other work-related ...

OrthoPediatrics

Supplier Quality Engineer

Warsaw, IN · On-site

... Medical Device Quality experience preferred. EDUCATION AND/OR EXPERIENCE: Requires a bachelor's degree in an Engineering discipline, or equivalent experience in a related quality role. ASQ ...

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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 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 Indiana?

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

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

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

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

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

Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in Indiana as of September 2026, with employment types broken down into 2% As Needed, 77% Full Time, 15% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution.

Quality Engineer I

Warsaw, IN • On-site

Zimmer Biomet
Medical Equipment and Supplies Manufacturing • 10K+ employees
Learn more about Zimmer Biometexternal

$60K - $78K/yr

Other

Posted 3 days ago

New

Zimmer Biomet rating

7.7

Company rating: 7.7 out of 10

Based on 99 frontline employees who took The Breakroom Quiz

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.


As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.


What You Can Expect

The Quality Engineer I is an entry level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. You will interact with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.


How You'll Create Impact

  • Formulates procedures, specifications, and standards for Zimmer products and processes.


  • Develops and implements corrective/preventative action plans.


  • Collects and analyzes data for gauge and product evaluation.


  • Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.


  • Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer Biomet.



What Makes You Stand Out

  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).


  • Ability to deliver, meet deadlines and have results orientation.


  • Good communication skills, both orally and in written form to multiple levels of the company.


  • Demonstrated characteristics of high potential for future development opportunities.


  • Good command of Microsoft Office Suite


  • Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.



Your Background

  • You hold a B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).


  • Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred



Travel Expectations

  • Up to 20%


EOE

#J-18808-Ljbffr

What Zimmer Biomet employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

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About Zimmer Biomet

Sourced by ZipRecruiter

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Warsaw, IN, US

Social media

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