About Me
A highly motivated and detail oriented Quality Assurance QA Executive of experience in ensuring the quality and compliance of medical devices, specifically within the In Vitro Diagnostics IVD industry. Proven expertise in regulatory standards such as ISO 13485, CE marking, and FDA 21 CFR Part 820. Adept at performing quality audits, managing corrective and preventive actions CAPA, conducting risk assessments, and ensuring strict adherence to Good Manufacturing Practices GMP.
Skilled in document control, process validation, and training team members on quality standards to ensure the development, manufacturing, and distribution of IVD products meet regulatory and customer expectations. Strong communicator, capable of collaborating with cross functional teams, including R&D, production, and regulatory affairs, to drive continuous improvements in product quality and manufacturing processes.
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