Quality, regulatory, technology, and business-results oriented Quality Professional with over twenty-four (24) years of experience in global manufacturing industries like medical devices, automotive, plastics and silicone molding (injection molding, transfer molding, blow molding) and consumer products. Responsibilities and experience have led to extensive & thorough knowledge of implementation of quality systems (ISO 13485, FDA 21 CFR 820, ISO 9001), Quality Audits (internal, Supplier & customer), CAPA, Supplier and Supply Chain Management, Root Cause Analysis, pFMEAs, Control Plans, GR&Rs, DoEs, SPC and proficiency in designing and writing Quality Manuals/Procedures/SOPs.