Design Quality Engineer
$50 per hourCoreTek Labs
Hiring: Design Quality Engineer
Location: USA (Bothell/Cambridge)
Type: Long Term Contract
Experience: 8+ Years
Rate: $50/hr
Key Skills:
✔ Design Control & Design Assurance
✔ 21 CFR Part 820 & ISO 13485
✔ Medical Device Regulations & Compliance
✔ Design Verification & Validation (V&V)
✔ DHF / DMR / DHR Traceability
✔ Engineering Change Control (ECR/ECO)
✔ Risk Management & FMEA
✔ CAPA & Root Cause Analysis
✔ QMS Processes & Audit Support
✔ Manufacturing Transfer & Change Management
✔ Design for Reliability
✔ FDA Regulated Medical Device Experience
✔ ISO 14971 & EU MDR
✔ Stakeholder & Cross-Functional Collaboration
✔ Product Quality & Regulatory Compliance
Vacancy posted 3 days ago
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