Design Quality Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-10-17
Listing for:
QvalFocus Inc.
Full Time
position Listed on 2026-10-17
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer
Job Description & How to Apply Below
Opportunity:
Design Quality Engineer Medical Devices
Location: Indiana (Onsite)
Contract Duration: 12 Months
Role OverviewWe are looking for a Quality Engineer to help ensure medical device products meet design quality, safety, and regulatory requirements throughout the development process. The ideal candidate will have a background in quality engineering, product risk assessment, nonconformance management, and CAPA within a regulated environment.
Key Responsibilities- Develop and improve quality processes to support product and manufacturing compliance.
- Evaluate product and process risks using FMEA and other risk assessment techniques.
- Investigate quality issues, document nonconformances, and coordinate appropriate corrective actions.
- Support root cause investigations and implement preventive measures to avoid recurring issues.
- Manage CAPA-related activities and verify the effectiveness of implemented solutions.
- Identify potential design, product, and patient safety concerns and help establish suitable risk mitigation strategies.
- Ensure quality activities align with applicable medical device regulations and industry standards.
- 2 5 years of experience in Quality Engineering, Quality Assurance, or a related function.
- Medical device manufacturing experience is highly desirable.
- Working knowledge of ISO 13485 and/or FDA 21 CFR Part 820.
- Bachelor s degree in Engineering or a related technical discipline, or equivalent practical experience.
- Experience applying ISO 14971 for medical device risk management.
- Familiarity with EU MDR 2017/745 requirements.
- Auditor or Lead Auditor certification is an advantage.
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