Position Details
About this role
This role involves supporting design quality activities for medical devices, including risk management, verification, validation, and regulatory compliance to ensure product safety and effectiveness.
Key Responsibilities
- Support design assurance activities
- Lead risk assessments and hazard analysis
- Ensure compliance with FDA and ISO standards
- Review and approve design verification and validation
- Collaborate with manufacturing and regulatory teams
Technical Overview
The position requires expertise in design verification, validation, risk assessments, and familiarity with FDA QSRs and ISO 13485 standards, focusing on medical device quality assurance.
Ideal Candidate
The ideal candidate is a mid-level Quality Engineer with experience in design assurance, risk management, and regulatory standards for medical devices. They should have a strong background in design verification and validation processes, and familiarity with FDA and ISO standards.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Clearance & Visa
Keywords for Your Resume
Deal Breakers
Lack of experience with medical device quality standards, No regulatory knowledge, No experience in design verification or validation
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