Associate Director Of Quality
CurrentMore than 18 years of R&D and Quality engineering experience within Medical Device IndustryIn-depth knowledge of FDA, ISO, IEC, JIS, YY, MDD/MDR, and other applicable standards as pertains to vascular access devicesManage and coordinate compliance of the global engineering and product development quality engineering functions. Provide strategic direction and support regarding global engineering and product life cycle management with respect to current or emerging quality, regulatory, and compliance issues. Assist in the development of tools or guidance documents to promote consistent implementation of the product development process and quality/compliance strategies.Support development and launch of short- or long-term vascular implanted devices, i.e., peripherally inserted catheters, Port, dialysis, CVC, enteral feeding and pleural effusion drainage devices, catheter tip-positioning system.Conduct investigations and use quality/reliability tools to solve problems in design, process, and test development and recommend/implement solutions.
