Customer-focused leader with 17 + years of experience pertaining Medical Device (Class II, III) / Pharma/ Combination Products/ Biologics / Disposables / Wound Management environment. • Experience in various Global Manufacturing Processes, Production Planning, Labeling, Operation Management, Risk Management, Design for Manufacturing (DFM), Design for Assembly (DFA), Change Control, Lean Manufacturing, Process Excellence, Advance Product Quality Planning (APQP), Global Performance Standards, and Device-Drug Master Records • Enterprise Experience in developing, establishing and implementing Quality Management Systems, Supplier Management, Value Engineering, 3PL management, Change Management Systems, Design Control, Management Reviews, Quality Assurance, Device Life Cycle Management, Project Management, Complaints, MDRs, post-marketing surveillance studies, and AE reporting.• Worldwide knowledge/experience with FDA Quality System Regulations (21 CFR Part 820), Good Manufacturing Practices (21 CFR 210-211), CFR 806, 807; ISO 13485, ISO 14971, GAMP 5, TUV, IPC, Canadian (CMDR), EU (MDD), CMDCAS, JPAL, TGA, BfArM, Eudralex, MHRA, IPC, ANVISA, ICH, QbD, USP, NDA, and cGCP. • Performed extensive audits for Drugs, Medical Devices, Vaccines, Pharma products and Sterile GMP audits of raw material suppliers, drug fabricators, APIs, EM sites, packagers and testing laboratories throughout North America, Europe, Asia Pacific, South Africa and Middle-East.• Proven experience in managing large teams globally, honing talent by focusing on, and refining, core competencies and skills, and help create personal and professional growth opportunities. • Strong background in Statistical Techniques and Hands-on experience in Taguchi Methods, Robust Design Methods, Hazard Analysis, Reliability Estimation, Accelerated Testing, HASS, FRACAS, DOE, SDLC process, and Six-Sigma.