Sixteen years of extensive research and production experience within the Diagnostics Industry, I bring a wealth of expertise to the table. My background encompasses a comprehensive understanding of the product development cycle for In vitro-Diagnostics medical devices.Throughout my career, I have demonstrated a proven track record in various key areas, including technology development, product design, execution, and effective team management. Notably, I excel in optimizing a diverse range of assays, including Lateral, Flow-through, Elisa and Quantitative assays.My proficiency extends to regulatory compliance, with a sound knowledge of ISO 13485, ISO 14971, and WHO PQ (IVD) standards. I am adept at navigating complex quality management systems and have hands-on experience with SAP and Q-Pulse System, facilitating efficient operations and streamlined processes within the organization.Overall, I am deeply committed to driving innovation, ensuring quality, and delivering impactful results in the field of Diagnostics.