Medical Device Quality Leader
1 day ago
About the Role
The Lead Quality Assurance Specialist will be responsible for ensuring the highest quality of medical devices, adhering to regulatory requirements and industry standards. This role involves collaborating with cross-functional teams to develop sterile and non-sterile medical devices.
Main Responsibilities
- Risk assessments and mitigation strategies
- Device testing and associated validations, including compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016
- Internal and external audits, serving as Subject Matter Expert (SME) for design processes
- Development and approval of technical documents on behalf of the Quality function
- Management of Design History Files (DHF)
- Continuous improvement of the Quality Management System (QMS)
Required Skills and Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline
- Minimum of 6 years' experience in Quality Assurance, Quality Systems, or Regulatory Affairs within the medical device industry
- In-depth knowledge of FDA regulations, ISO standards, and international medical device regulations
About Us:
We specialize in sourcing professionals for key industries and services, providing opportunities for growth and development.
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