Design Quality Engineer
Job in
Lakewood, Ocean County, New Jersey, 08701, 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
.
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