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Senior Quality Engineer Medical Device Jobs in Indiana

Synkriom

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Quality Engineer Medical Device

Warsaw, IN · On-site

$40 - $45/hr

B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE). Company Description Founded in 2015 and backed by two decades of hands-on ...

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Flotec

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Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based medical device manufacturer specializing in respiratory and oxygen delivery equipment. We manufacture ...

CTE Solutions

Senior Quality Engineer

Plymouth, IN · On-site

$80K - $109K/yr

Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Reviewing and ... Strong background in quality control and quality engineering functions * Understanding GD&T

Watkins Wellness

Sr. Quality Engineer

Indianapolis, IN · On-site

$89 - $139/hr

The Senior Quality Engineer is responsible for applying Quality Engineering principles and tools to ... medical condition, marital/domestic partner status, military and veteran status, height, weight or ...

Trojan Battery Company

Sr. Quality Engineer

Attica, IN · On-site

$75K - $101K/yr

Position Overview The Senior Quality Engineer coordinates and implements effective processes, product, and component control plans. Utilizing basic 6 Sigma tools such as: Root Cause and Corrective ...

C&D Technologies, Inc.

Sr. Quality Engineer

Attica, IN · On-site

$75K - $101K/yr

Position Overview The Senior Quality Engineer coordinates and implements effective processes, product, and component control plans. Utilizing basic 6 Sigma tools such as: Root Cause and Corrective ...

Masco Corporation

Sr. Quality Engineer

Indianapolis, IN · On-site

$84K - $114K/yr

The Senior Quality Engineer works independently with minimal supervision, leads complex quality ... medical condition, marital/domestic partner status, military and veteran status, height, weight or ...

Cleveland--cliffs-1

Senior Quality Engineer

Burns Harbor, IN · On-site

$110 - $140/hr

The Senior Quality Engineer is responsible for supporting the daily quality activities, including ... If, because of a medical condition or disability, you need a reasonable accommodation for any part ...

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AK Steel

Senior Quality Engineer

Burns Harbor, IN

$82K - $111K/yr

The Senior Quality Engineer is responsible for supporting the daily quality activities, including ... If, because of a medical condition or disability, you need a reasonable accommodation for any part ...

avalign

Sr. Design Quality Engineer

Fort Wayne, IN

The Design Quality Engineer will be responsible for the quality and regulatory related activities ... Support processes for Medical Device Reporting and Complaints for Avalign as specification ...

Eightelevengroup

Software Quality Engineer

Warsaw, IN · On-site

$76 - $88/hr

Software Quality Engineer Warsaw, IN Hybrid role (3 days in office) $55 - $64 per hour ABOUT THE ... Support the design, development, and testing of medical device software, including Software as a ...

Trojan Battery Company

Engineer, Quality (CDT)

Attica, IN

$61K - $78K/yr

Work with a Sr. Quality Engineer driving process improvement and developing problem solving plans thru 6 Sigma principals Development and review of Root Cause and Corrective Action (RCCA) plans ...

Actalent

Quality Engineer

Warsaw, IN

$60K - $78K/yr

Quality Engineer - New Product Development (Medical Devices) This role provides lead quality engineering support to New Product Development teams to ensure new and improved medical device products ...

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Senior Quality Engineer Medical Device information

What is a senior quality engineer medical device?

Senior Quality Engineers in the medical device industry are professionals responsible for ensuring that medical devices meet regulatory standards and quality requirements throughout their lifecycle. They lead quality assurance activities, develop and implement testing protocols, coordinate with design and manufacturing teams, and help ensure compliance with relevant regulations such as FDA and ISO standards. Their expertise ensures that products are safe, effective, and reliable for patient use. They also mentor junior engineers and may play a key role in audits and process improvements.

How does a senior quality engineer medical device typically collaborate with cross-functional teams during product development?

As a Senior Quality Engineer in the medical device sector, you will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain. Your role involves ensuring quality standards are integrated throughout the product lifecycle, from design reviews and risk assessments to process validation and compliance documentation. Regular meetings, joint problem-solving sessions, and clear communication are vital to resolve issues efficiently and maintain regulatory compliance. This collaborative environment helps to ensure both product safety and timely market release.

What are the key skills and qualifications needed to thrive as a senior quality engineer medical device, and why are they important?

To excel as a Senior Quality Engineer in Medical Devices, you need a solid background in engineering, quality assurance, and regulatory compliance, typically with a relevant degree and experience in the medical device industry. Familiarity with ISO 13485, FDA 21 CFR Part 820, risk management tools (such as FMEA), and quality management systems is crucial, and certifications like CQE or Six Sigma are often preferred. Strong problem-solving, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure product safety, regulatory compliance, and the continuous improvement of processes critical to patient outcomes and company success.

What is the difference between Senior Quality Engineer Medical Device vs Quality Engineer Medical Device?

AspectSenior Quality Engineer Medical DeviceQuality Engineer Medical Device
ResponsibilitiesLead quality initiatives, oversee audits, mentor team membersAssist in quality processes, support audits, perform inspections
Experience & CertificationsTypically 5+ years, often ISO 13485, FDA regulationsEntry to mid-level, basic knowledge of industry standards
Work EnvironmentLeadership roles, cross-functional teams, strategic planningOperational tasks, documentation, compliance support
Usage & IndustryCommonly used in manufacturing, R&D, and quality departmentsUsed across similar settings, often as a stepping stone role

The main difference between a Senior Quality Engineer Medical Device and a Quality Engineer Medical Device lies in experience, responsibilities, and leadership scope. Senior roles involve strategic oversight and mentorship, while standard Quality Engineers focus on supporting quality processes and compliance tasks.

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 Senior Quality Engineer Medical Device jobs in Indiana?

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

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

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

What cities in Indiana are hiring for Senior Quality Engineer Medical Device jobs?

Cities in Indiana with the most Senior Quality Engineer Medical Device job openings:

Senior Quality Engineer Medical Device jobs near you
Infographic showing various Senior Quality Engineer Medical Device job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, and 5% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution.

Quality Engineer Medical Device

Warsaw, IN • On-site

Synkriom
IT Services • 51 - 200 employees
Learn more about Synkriomexternal

$40 - $45/hr

Contractor

Medical, Dental, Vision, Life

Posted yesterday

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Job description

Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities.  Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.

Principal Duties and Responsibilities:

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.

Skills:

  • 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.
  • Able to communicate both orally and in written form to multiple levels of the company.
  • Demonstrates characteristics of high potential for future development opportunities.
  • Microsoft Office Suite

Proficient in blueprint reading and geometric dimensioning and tolerancing, thorough understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.

Education:

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

Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.