Samantha Shelley - Quality Manager
After starting her career as a mechanical engineer specialising in quality assurance, Sam began working in the medical devices field, quickly adding regulatory affairs to her quality management systems responsibility. She has held various positions in quality systems management, compliance and regulatory affairs with a wide range of medical device manufacturers and sub-contract manufacturers, for devices as diverse as metered dose inhalers, extreme orthopaedic implants, breast implants and lasers.
Her experience in manufacturing systems, human factors, auditing, supply chain quality management, post market surveillance and Competent Authority/Notified Body relationship management, combined with a natural pragmatism, results in a simple, but robust and effective quality management system that supports the evolution of products and services.
Sam has been responsible for successfully hosting FDA inspections, Notified Body audits and CE marking of Class IIa products and has experience in the manufacture of and regulations affecting medical devices of all classes.
A keen and fairly accurate clay pigeon shooter, Sam is based in Surrey and enjoys long walks in the Royal Parks with her Cocker Spaniel, Nell, celebrity spotting (lives in very close proximity to a major film studio site) and gardening.