Senior Engineering Manager with more than seventeen years experience in medical device manufacturing with world class companies; rigorous FDA quality requirements for medical industries. Extensive experienced and knowledge of Quality Systems Implementation, Cell Business Unit operations, Multi-site Operations and Training/Mentoring at all levels—Kepner Tregoe certified. Managed budget exceeding $2MM; Recognized expert in Continuous Improvement Processes, Lean Manufacturing, Six Sigma, TQM, ISO, FDA, and Japan PMDA. Additional strengths in Team Building, Dynamics and metrics developer, SOPs, validation/qualification protocols, and CAPA. Strong strategic thinking, self starter, detailed and result oriented. Fully bilingual.