Desmond Lewis CQE CRE CQM PMP is a professional with extensive experience in quality assurance and regulatory affairs in the medical device industry. They have held roles ranging from Quality Engineer to Director of Quality, overseeing various aspects such as project management, supplier quality, audits, and quality systems implementation. Their background includes working with companies like Boston Scientific, IMRIS, and Smiths Medical, as well as consulting for start-up medical device manufacturing companies. Desmond also has experience in lean manufacturing practices, 510k submissions, and compliance with regulatory standards such as ISO 13485 and FDA regulations.
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