Design Quality Engineer
Job in
Toms River, Ocean County, New Jersey, 08757, USA
Listed on 2026-10-01
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-10-01
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Seeking a Design Quality Engineer with strong medical device experience to support product development, design controls, risk management, and quality activities throughout the product lifecycle.
Required Experience:- 3–4 years of Design Quality / Quality Engineering experience in the medical device industry
- Strong experience with Design Controls, DHF, DMR, and Design History documentation
- Hands-on knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
- Experience with Risk Management, FMEA, and risk assessments
- Experience supporting NPI, Design Transfer, Verification & Validation
- Knowledge of CAPA, NCR/Nonconformance, deviations, and change control
- Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or related field
- Support Design Quality activities throughout the product development and NPI lifecycle
. - Review and approve design and quality documentation in compliance with regulatory requirements.
- Support design reviews, risk management, FMEA, V&V, and design transfer activities.
- Partner with R&D, Engineering, Manufacturing, and Regulatory teams to resolve quality issues.
- Support CAPA, NCRs, investigations, and change control activities.
- Ensure products and processes meet applicable medical device quality and regulatory standards
.
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:
×