Design Quality Engineer

QvalFocus Inc.; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

QvalFocus Inc. in Indiana is seeking a Design Quality Engineer for medical devices to ensure design quality, safety, and regulatory compliance throughout development.

You will lead quality processes, perform risk assessments (FMEA), investigate nonconformances, drive CAPA, and collaborate with cross‑functional teams to mitigate design and patient safety risks while aligning with ISO 13485 and FDA requirements.

Qualifications

• 2–5 years of experience in Quality Engineering, QA, or 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 related technical discipline, or equivalent practical experience.

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.

Skills

Quality engineering

CAPA

FMEA

Education

Bachelor's degree in Engineering

Tools

ISO 13485

FDA 21 CFR Part 820

Job description

Opportunity: Design Quality Engineer Medical Devices

Location: Indiana (Onsite)

Contract Duration: 12 Months

Role Overview

We 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.

Required Qualifications

• 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.

Preferred Qualifications

• Experience applying ISO 14971 for medical device risk management.
• Familiarity with EU MDR 2017/745 requirements.
• Auditor or Lead Auditor certification is an advantage.