Position Details
About this role
This role involves providing quality oversight and strategic leadership for medical device design and development activities, ensuring compliance with regulatory standards and driving continuous improvement.
Key Responsibilities
- Provide quality oversight
- Support Risk Management and Design Control
- Review and approve DHF and V&V plans
- Ensure compliance with 21 CFR 820.30 and ISO 13485
- Lead or facilitate design reviews
Technical Overview
The technical scope includes design control, risk management, design verification and validation, and regulatory submissions within the medical device industry, with a focus on FDA and ISO standards.
Ideal Candidate
The ideal candidate is a senior quality assurance engineer with 8+ years of experience in medical device design quality, regulatory compliance, and risk management. They possess strong leadership skills and extensive knowledge of FDA and ISO standards.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with FDA 21 CFR 820.30 or ISO 13485, No experience in medical device quality assurance, No regulatory compliance background
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