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Quality Engineer Medical Devices Jobs in Indiana

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Quality Engineer

Avon, IN ยท 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 ...

Quality Engineer

Franklin, IN ยท On-site

$67K - $87K/yr

The Quality Engineer will work closely with operations and engineering to reduce scrap and drive ... Medical Devices Industry). * LEAN/6 sigma experience a plus. * Demonstrated knowledge and ...

... medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in ... Quality Engineer II Working at Abbott At Abbott, you can do work that matters, grow, and learn ...

Quality Engineer II

Westfield, IN ยท On-site

$61K - $122K/yr

... medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in ... Quality Engineer II Working at Abbott At Abbott, you can do work that matters, grow, and learn ...

Quality Engineer

Logansport, IN ยท On-site

$66K - $85K/yr

As one of the world's leading manufacturers of notebook PCs, smart devices, data center equipment ... ABOUT THE ROLE We are seeking a Quality Engineer to join our team in our Logansport, Indiana ...

Quality Engineer

Logansport, IN ยท On-site

$66K - $85K/yr

As one of the world's leading manufacturers of notebook PCs, smart devices, data center equipment ... ABOUT THE ROLE We are seeking a Quality Engineer to join our team in our Logansport, Indiana ...

... medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in ... Quality Engineer II Working at Abbott At Abbott, you can do work that matters, grow, and learn ...

Quality Engineer

Logansport, IN ยท On-site

$66K - $85K/yr

As one of the world's leading manufacturers of notebook PCs, smart devices, data center equipment ... ABOUT THE ROLE We are seeking a Quality Engineer to join our team in our Logansport, Indiana ...

Quality Engineer

Logansport, IN ยท On-site

$66K - $85K/yr

As one of the world's leading manufacturers of notebook PCs, smart devices, data center equipment ... ABOUT THE ROLE We are seeking a Quality Engineer to join our team in our Logansport, Indiana ...

Quality Engineer

Indianapolis, IN ยท On-site

$68K - $88K/yr

... Medical Devices, and Commercial market segments. Our mission is to engage customers and empower ... Support the Quality Techs in CMM Programming with Calypso Software and inspecting parts on the CMM.

Quality Engineer

Indianapolis, IN

$68K - $88K/yr

... Medical Devices, and Commercial market segments. Our mission is to engage customers and empower ... Support the Quality Techs in CMM Programming with Calypso Software and inspecting parts on the CMM.

Quality Engineer

Indianapolis, IN

$68K - $88K/yr

The Quality Engineer is responsible for providing oversight for commissioning and qualification ... medical devices, and auditing. * Vision requirements for this position: Near Vision Acuity with ...

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Showing results 1-20

Quality Engineer Medical Devices information

See Indiana salary details

$42.8K

$80K

$113.2K

How much do quality engineer medical devices jobs pay per year?

As of Jul 26, 2026, the average yearly pay for quality engineer medical devices in Indiana is $79,968.00, according to ZipRecruiter salary data. Most workers in this role earn between $68,500.00 and $88,500.00 per year, 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 products meet regulatory standards and quality requirements throughout their lifecycle. They develop and implement quality control processes, conduct risk assessments, lead investigations into product defects, and work closely with cross-functional teams to ensure compliance with regulations such as FDA and ISO 13485. Their work helps to guarantee the safety, reliability, and effectiveness of medical devices before they reach patients.

How does a Quality Engineer collaborate with cross-functional teams in the medical device industry?

Quality Engineers in the medical device field work closely with design, manufacturing, and regulatory teams to ensure products meet stringent quality and compliance standards. They participate in design reviews, help develop verification and validation protocols, and support the implementation of corrective actions. Regular communication with production and R&D teams is essential to identify potential risks early and to ensure that quality is built into every stage of product development. This collaborative approach not only improves product safety and efficacy but also streamlines regulatory submissions and audits.

What is the difference between Quality Engineer Medical Devices vs Quality Technician Medical Devices?

AspectQuality Engineer Medical DevicesQuality Technician Medical Devices
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, basic quality certifications
ResponsibilitiesDesigning quality systems, process improvements, root cause analysisInspecting products, conducting tests, recording quality data
Work EnvironmentDesign and development labs, manufacturing plantsManufacturing floors, quality control labs
Employer & Industry UsageMedical device companies, OEMs, suppliersManufacturers, contract labs, quality departments

In summary, Quality Engineer Medical Devices focus on developing quality systems, process improvements, and ensuring compliance, while Quality Technicians primarily perform product inspections and testing. Both roles are essential in maintaining high standards in the medical device industry but differ in scope and responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in Medical Devices, and why are they important?

To thrive as a Quality Engineer in Medical Devices, you typically need a degree in engineering or a related field, combined with knowledge of quality assurance principles and regulatory requirements (such as ISO 13485 and FDA regulations). Familiarity with risk management tools, validation protocols, and quality management systems (QMS), as well as certifications like CQE (Certified Quality Engineer), are highly valuable. Strong analytical thinking, attention to detail, and effective communication skills enable you to identify issues, collaborate with cross-functional teams, and ensure compliance. These competencies are crucial for maintaining product safety, meeting regulatory standards, and supporting a culture of continuous improvement in the medical device industry.
What are popular job titles related to Quality Engineer Medical Devices jobs in Indiana? For Quality Engineer Medical Devices jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Quality Engineer Medical Devices jobs in Indiana look for? The top searched job categories for Quality Engineer Medical Devices jobs in Indiana are:
Infographic showing various Quality Engineer Medical Devices job openings in Indiana as of July 2026, with employment types broken down into 1% As Needed, 76% Full Time, 17% Part Time, 1% Temporary, 4% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $79,968 per year, or $38.4 per hour.

Sr Systems Analysis Engineer, Medical Devices

Wright Technical Services

Bloomington, IN โ€ข On-site

$96K - $132K/yr

Other

Posted 23 days ago


Job description

Overview

This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables.

Responsibilities:

  • Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, and user stories.
  • Conduct risk management activities including risk analysis for system, software, and cybersecurity.
  • Lead systems integration efforts across various engineering disciplines.
  • Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
  • Ability to effectively work and communicate in technical cross-functional teams to develop new products.
  • Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve work processes.

Required Qualifications:

  • BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
  • Minimum of 5 years of experience analyzing system requirements, design, and testing
  • Software integration, and black box testing methodologies
  • Experience with multi-tasking real-time operating system
  • Agile development experience
  • Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971
  • Experience and understanding of Design Controls and SDLC

Preferred Qualifications:

  • Familiarity with best practices of software development for medical devices
  • Strong Project Management skills
  • Familiarity with Agile, GitHub, and Azure Dev Ops

Physical Requirements:

  • Works under general office environmental conditions
  • Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
  • Ability to travel 25% of the time