Self-motivated medical industry professional with knowledge and experience of remediation in the highly regulated medical device, pharmaceutical and biotechnology markets, in particular sterile products. Skilled in developing and implementing strategic remediation plans, for example those aimed at DHF completion and CAPA compliance, including completion of verification, validation and effectiveness actions. Excellent track record in Quality Systems, Validation and Risk Management projects in Medical Industry projects. Recent projects have included; Design History File remediation, Risk Management according to ISO 14971, preparation and updating of pFMEA, dFMEA, Risk management Plans, Risk management reports, and change control optimisation for deviations. Hands on approach to problem solving, project development and remediation activities.