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Senior Quality Engineer Medical Device Jobs in Indiana

Flotec

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

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

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 ...

Trojan Battery Company

Engineer, Quality (CDT)

Attica, IN · On-site

$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 ...

Optimal Inc.

Sr. Quality Engineer

Elkhart, IN · On-site

$80K - $85K/yr

The Sr. Quality Engineer plays a key role in ensuring the highest standards of quality, reliability, and performance for integrated mechanical and electrical systems. This position requires a ...

Optimal Inc.

Sr. Quality Engineer

Elkhart, IN · On-site

$80K - $85K/yr

The Sr. Quality Engineer plays a key role in ensuring the highest standards of quality, reliability, and performance for integrated mechanical and electrical systems. This position requires a ...

Optimal Inc.

Sr. Quality Engineer

Elkhart, IN

$85K - $115K/yr

The Sr. Quality Engineer plays a key role in ensuring the highest standards of quality, reliability, and performance for integrated mechanical and electrical systems. This position requires a ...

C&D Technologies, Inc.

Engineer, Quality (CDT)

Attica, IN · On-site

$61K - $78K/yr

Trend analysis, Monthly Reports, corrective actions • Work directly with the Sr. Quality Engineer on supplier quality performance for all purchased parts for company production use. • Develop and ...

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/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 ...

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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.

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 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.

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 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, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Senior Quality Engineer- Medical Device MFg

TekWissen

Warsaw, IN • On-site

$85K - $115K/yr

Full-time

Re-posted 27 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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