What are the responsibilities and job description for the Design Quality Engineer position at CoreTek Labs?
🚀 Hiring: Design Quality Engineer (DQE)
📍 Location: Bothell, WA / Cambridge, MA
💼 Type: Long Term Contract
We're looking for an experienced Design Quality Engineer with strong experience in FDA-regulated Medical Device environments.
🔹 Key Skills:
✔Design Quality Engineering (DQE)
✔Design Control (21 CFR Part 820, ISO 13485)
✔Risk Management (ISO 14971)
✔Design Verification & Validation (V&V)
✔DHF, DMR, DHR Documentation
✔Design Reviews & Traceability Matrix
✔ECR/ECO & Change Management
✔Design Transfer to Manufacturing
✔FMEA & Hazard Analysis
✔CAPA & Root Cause Analysis
✔QMS & Regulatory Compliance
✔EU MDR / FDA Medical Devices
✔Medical Device Product Development