Design Quality Engineer – Medical Devices C2C
Job in
North Bothell Area, Snohomish County, Washington, 98021, USA
Listed on 2026-07-04
Listing for:
Tech Mirrors
Contract
position Listed on 2026-07-04
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
Job Title:
Design Quality Engineer - Medical Devices
Location:
Bothell, WA
Work Mode:
Onsite
Client:
Tata Elxsi | Philips
We are looking for a Design Quality Engineer (DQE) with experience in medical devices and FDA-regulated environments. The role involves supporting product quality throughout the design and development lifecycle, ensuring compliance with regulatory and quality standards.
Key Responsibilities- Support Design Control activities as per FDA and ISO standards
- Participate in design reviews, verification, and validation activities
- Review design documents, technical files, and change requests (ECR/ECO)
- Maintain traceability documentation including DHF, DMR, and DHR
- Support design transfer activities to manufacturing
- Drive Risk Management activities including FMEA and hazard analysis
- Ensure implementation and documentation of risk controls
- Support CAPA activities, root cause analysis, and audit readiness
- Work closely with cross-functional teams including R&D, Manufacturing, and Regulatory
- 5+ years of experience in FDA-regulated medical device environments
- Strong knowledge of Design Control and Design Assurance processes
- Experience with Risk Management and Design for Reliability
- Familiarity with: 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and other medical device regulations
- Experience with change management and manufacturing transfer
Bachelor’s Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field.
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