Design Quality Engineer
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-09-25
Listing for:
Excelon Solutions
Full Time
position Listed on 2026-09-25
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- Hands-on experience in medical device design and development.
- Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD).
- Hands-on experience in Component Qualification and Process Validation activities.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
- Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
- Review and approve DHF deliverables and quality documentation.
- Review and approve verification, validation, and design transfer deliverables.
- Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
- Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
- Assess product, process, and supplier changes for quality and regulatory impact.
- Participate in CAPA, and nonconformance investigations.
- Analyze quality metrics and complaint trends to drive continuous improvement.
- Serve as a Design Quality SME during audits, inspections, and design reviews.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×