Ten years experience in Manufacturing, NPI, Quality, Supplier Quality of Medical Devices industry making Laser Surgical Devices, Medical Robotics, Silicone Gel Implantation, Heart Valves, Catheters.Verification and Validation of medical processes, materials, equipments, and devices. Wrote, executed and got signed-off protocols and reports of IQ, OQ, PQ.Class II and Class III medical devices in the key technology areas of medical materials and processes including contamination control, cleaning technologies, bioburden reduction, sterilization, chemical treatment, coatings, polymers, packaging. Unique hands-on training and working experience in medical devices technologies and regulatory compliances of QMS. Trained and worked with AAMI/ISO and FDA Quality System Regulation 21 CFR 820. Led, planned, implemented projects relating to FMEA, Risk Management, SPC, Gauge Capability, audits, cost reduction, yield improvements and continuous improvements.