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Quality Engineer Medical Device Jobs in Indiana (NOW HIRING)

EHOB INC

Quality Assurance Engineer

Indianapolis, IN · On-site

Summary The Quality Assurance Engineer will support the organization towards compliance of ... Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device ...

360 IT Professionals

Quality Engineer

Warsaw, IN

$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 ...

Abbott

Quality Engineer I

Westfield, IN · On-site

$50K - $101K/yr

Quality Engineer I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care ... Medical Device experience Apply Now Learn more about our health and wellness benefits, which ...

Abbott

Quality Engineer I

Westfield, IN

$50K - $101K/yr

Quality Engineer I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care ... Medical Device experience Apply Now Learn more about our health and wellness benefits, which ...

Abbott

Quality Engineer I

Westfield, IN · On-site

$50K - $101K/yr

Quality Engineer I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care ... Medical Device experience Apply Now Learn more about our health and wellness benefits, which ...

Zimmer, Inc.

Quality Sr Engineer II

Warsaw, IN · Hybrid

$85K - $115K/yr

Facilitates team efforts on quality engineering projects. * Ability to deliver, meet deadlines and ... medical device industry strongly preferred. Travel Expectations Up to 20% EOE Employment Type:

Prophecy Technologies

Quality Engineer

Indianapolis, IN · On-site

$68K - $88K/yr

* Support Design History File (DHF) activities for medical device development projects. * Review ... Review engineering documents for completeness, accuracy, and compliance with quality system ...

Siri InfoSolutions Inc

Manufacturing Engineer

Warsaw, IN · On-site

$70K - $90K/yr

Medical Device Manufacturing Engineer Location: Warsaw, IN Duration: 6+ months Experience Required ... Works with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning ...

Anonymous Employer

Quality Engineer

Greenwood, IN · On-site

$40.87 - $45.67/hr

Up to $95,000 base + Quarterly Bonus , Medical, Dental, Vision & 401(k) Contribution Role Overview The Quality Engineer ensures the highest level of product quality and compliance within a regulated ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Indiana

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 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.
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 August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 16% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Design Quality Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Posted 17 days ago

Job description

Location: ~Indianapolis, IN~ (REMOTE)
Duration: 6 months
Design Quality Engineer
Technical/Functional
Skills • Strong understanding of Medical Device Product Development Process and Design Control requirements. • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards. • Strong knowledge of Design Controls and medical device product development. • Experience with Design History File (DHF) development, review, and remediation.
• Hands-on experience with Risk Management activities including: o dFMEA o uFMEA o Preliminary Hazard Analysis (PHA) o Hazard Analysis • Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971. • Experience with Design Verification and Validation (V&V). • Understanding of User Needs, Design Inputs, Design Outputs, and Traceability requirements. • Experience preparing and reviewing: o Product Specification Documents (PSD) o Product Characterization documents o CTQ (Critical-to-Quality) documents • Experience with CAPA, Nonconformance, and root cause investigations. • Familiarity with PLM systems such as Windchill, or Teamcenter. • Experience with Cockpit Cognition DHF Build and DHF traceability management. • Strong documentation, technical writing, and audit support skills.
Roles & Responsibilities • Support quality activities throughout the product development lifecycle. • Review and maintain Design History File (DHF) documentation for compliance with regulatory and quality requirements. • Lead and support risk management activities including dFMEA, uFMEA, and PHA updates. • Ensure traceability between User Needs, Design Inputs, Risk Controls, Verification, Validation, and Design Outputs. • Support Design Verification and Validation planning, execution, and documentation reviews. • Review Product Characterization, Product Specification (PSD), and CTQ documents. • Participate in design reviews and ensure compliance with
Design Control processes. • Support Cockpit Cognition DHF Build activities, including documentation organization and traceability linkages. • Conduct DHF gap assessments and support remediation activities. • Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams. • Support CAPA investigations, root cause analysis, and implementation of corrective actions. • Ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality procedures. • Support internal audits, customer audits, and regulatory inspections. • Drive continuous improvement initiatives related to design quality and risk management processes.

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