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Quality Assurance and Medical Device Expert
5 days ago
A dynamic and experienced professional is sought to lead quality assurance processes and ensure regulatory compliance for medical devices.
This individual will collaborate with cross-functional teams to achieve successful product commercialization and maintain ongoing regulatory compliance.
Primary responsibilities:
- Perform thorough product inspections and testing, adhering to industry standards.
- Host external audits and inspections, demonstrating exceptional professionalism.
- Conduct internal and supplier audits, identifying opportunities for improvement.
- Oversee timely product registrations as required per market.
- Manage the Quality Management System (QMS), optimizing efficiency and effectiveness.
Candidates must possess the following skills and qualifications:
- University degree in life science, engineering, or related field, serving as a solid foundation.
- Significant experience (+5 years) in operational and strategic QA and RA roles within the medical device industry.
- Expertise in global product registration, applying knowledge to drive business expansion.
- Familiarity with relevant regulations, such as MDR, 21CFR Part 820, ISO 13485, ISO 14971, and ISO 11135.
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