Broad experience in Quality, Manufacturing and R&D, for ISO certified/FDA regulated medical device manufacturers. Product knowledge spans Class I, II & III devices, encompassing: operating room accessory kits, gastrointestinal endoscopic devices, urological devices, and vascular devices with a focus on minimally invasive technology. Related areas of expertise are:

Quality Systems, Project management. Process optimization, Packaging, Process validation, Design control, Risk management, Materials management, Metrology, Sterilization (EO, Gamma, Steam, VHP), Regulatory Affairs