Design Quality Engineer

Akkodis is seeking a Design Quality Engineer for a Contract with a client in Indianapolis, IN (Remote). The ideal candidate will support design quality activities throughout the medical device product development lifecycle by ensuring compliance with design controls, risk management, and regulatory requirements.


Rate Range: $32/hour to $34/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.


Design Quality Engineer Job Responsibilities include:

• Support quality and compliance activities throughout the medical device product development lifecycle, ensuring adherence to Design Control requirements.
• Review, maintain, and remediate Design History File (DHF) documentation to ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality standards.
• Lead and support risk management activities, including dFMEA, uFMEA, Preliminary Hazard Analysis (PHA), hazard assessments, and risk control implementation.
• Ensure end-to-end traceability between User Needs, Design Inputs, Design Outputs, Risk Controls, Verification, and Validation requirements.
• Support Design Verification and Validation (V&V) planning, execution, documentation reviews, and participation in design review activities.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Quality teams to support CAPA investigations, root cause analysis, audits, regulatory inspections, and continuous improvement initiatives.

Required Qualifications:

• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, Life Sciences, or a related technical field.
• 5+ years of experience in Design Quality, Quality Engineering, or Medical Device Product Development within a regulated environment.
• Strong hands-on experience with Design Controls, Design History Files (DHF), Risk Management (dFMEA, uFMEA, PHA), and Design Verification & Validation (V&V) activities in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Proven ability to manage traceability requirements, support CAPA and root cause investigations, conduct DHF remediation activities, and collaborate with cross-functional teams to ensure regulatory and quality compliance throughout the product development lifecycle.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Shashank.Tewari@ akkodisgroup.com.


Pay Details: $32.00 to $34.00 per hour


Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.


Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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