This candidate is a highly skilled Quality Assurance and Document Control Specialist with over four years of dedicated experience within the medical device and In Vitro Diagnostic (IVD) sectors. They possess a deep practical understanding of ISO 13485:2016 and IVDR requirements, having successfully supported multiple BSI certification and re-certification cycles. Their expertise spans the entire product lifecycle, from managing technical documentation in R&D environments to overseeing rigorous change control and regulatory auditing in mature manufacturing settings.
A specialist in digital transformation within regulated environments, the candidate has a proven track record of implementing and maintaining electronic Quality Management Systems (eQMS) and Product Lifecycle Management (PLM) platforms, including Q-Pulse, MasterControl, and Agile. They are a Lean-certified professional who successfully reduced average document processing turnaround times by 55% within a four-month period. As a trained internal auditor, they excel at identifying workflow bottlenecks, performing root cause analysis (8D/G8D), and driving operational excellence through cross-functional training and robust risk management (ISO 14971).
Unique to this candidate is a strong academic and laboratory foundation, holding an MSc in Biomedical Studies and prior experience as a Product Development Scientist. This "bench-to-boardroom" perspective allows them to bridge the gap between technical R&D and quality compliance. They are proficient in molecular techniques such as qPCR, PCR, and automated extraction (e.g., QIAsymphony), enabling them to author precise technical protocols and validation reports that meet stringent regulatory standards while remaining scientifically sound.
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