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Senior Quality Assurance Specialist
2 months ago
As a key member of our team at EPM Scientific, you will serve as the Quality Assurance lead for Design Control, overseeing business-critical new product development projects and external partnership programs. Your expertise will ensure that state-of-the-art requirements are maintained throughout the product lifecycle.
Key Responsibilities:- Critically review and approve analytical and clinical study protocols and reports to assess quality, identify gaps, and provide mitigations that support successful new product development.
- Define regulatory strategy and plans for clearance/approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD, and Companion Diagnostics markets.
- Mentor and coach LBS Quality Assurance professionals in their development and support building team capabilities.
- Extensive experience in medical device industry covering Innovation and Design Control.
- Substantial experience in commercial product development including transfer of complex feasibility projects into product commercialization.
- Extensive knowledge of international IVD medical device quality systems including 21 CFR 820, ISO 13485, and the MDSAP programme.
We are looking for a highly skilled and experienced professional to join our team and contribute to the success of our company. If you have a passion for quality assurance and regulatory affairs, and a strong background in medical device development, we encourage you to apply for this exciting opportunity.
