William Hume

Quality Assurance Engineer with 4+ years experience within the IVDR Medical Device industry. Working in alignment to FDA Regulation, ISO requirements and CE Marking. Currently employed at DNAe (London) working on the implementation of the eQMS systems in alignment to FDA regulations and ISO standards. My key responsibilities are: - Conceptualizing standard operating produces for product development - Implementation of QA processes conforming to regulatory requirements - Assisting and leading Non-Conformance actives - Assisting in the development of Supplier Selection and Approval process - Ensuring GDP is maintained Previous employed as a Pre-Production Quality Control Analyst at globally recognized IVDR Medical Device Manufacturer - Ortho Clinical Diagnostic. Leading and assisting Stability Trials for newly developed testing kits, my key responsibility were: - Development of Stability Study Plans - Executing stability study activities and trials - Production of Stability Study Reports - Analysis and management of Stability Study Data - Lead studies based on NC and customer complaints