Design Quality Assurance II – Medical Devices

About the role

Support an exciting medical device integration project.

Tasks

• Support medical device design quality and design assurance activities
• Ensure compliance with design control requirements and regulatory standards
• Maintain and review Design History Files (DHF) and design documentation
• Support design verification and validation (V&V) activities
• Conduct risk assessments, hazard analysis, and FMEA
• Support design reviews, design changes, and requirements traceability
• Collaborate with R&D, Quality, Regulatory, and Engineering teams
• Support CAPA, risk mitigation, and regulatory audit readiness

Requirements

• 3–5 Years
• Medical Device Design Quality / Design Assurance – MUST HAVE
• Design Controls – MUST HAVE
• ISO 14971 – MUST HAVE
• ISO 13485 – MUST HAVE
• FDA 21 CFR Part 820 – MUST HAVE
• Design History File (DHF) Documentation
• Design Verification & Validation (V&V)
• Risk Management, FMEA & Hazard Analysis
• Requirements Traceability & Design Reviews
• CAPA & Root Cause Analysis
• MDSAP / EU MDR – Preferred
• Design Transfer & Medical Device Product Development – Preferred
• A Design Quality Engineer with hands-on medical device experience, strong knowledge of design controls, DHF documentation, risk management, and design verification and validation, along with a solid understanding of FDA and ISO regulatory requirements.

Schedule

• Remote or Onsite (W2 ONLY NO C2C)
• Contract

How to apply

• Share your updated resume by email.

Location

• Irvine, CA