More jobs:
Quality Engineer
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-01-04
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-01-04
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
Job Title: Design Quality Engineer
Location: Irvine, CA (Onsite)
OverviewSeeking a Design Quality Engineer II to support medical device new product development by ensuring compliance with design controls, risk management, and regulatory requirements. The role focuses on quality system support, design verification and validation, and successful transfer of products to manufacturing.
Required Experience- Design Controls (FDA 21 CFR 820, ISO 13485)
- Design Verification & Validation (DV/VV planning and reporting)
- Ability to read and interpret CAD drawings
- Strong knowledge of US and international medical device regulations
- Quality systems experience (CAPA, audits, statistics)
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