Experience:High performing Quality Systems Management executive. Expertise in building/optimizing organizational processes, Considerable experience in OSM Quality Systems transformation to electronic environments. Significant Regulatory and Quality Experience from ISO9001 to 13485Currently working on Multiple IOSM reform processes including 3604 Reforms, BCA MOU's and Developing the next phase being OSM onsite compliance model.Extensive scope of responsibility, proven success records, Track record of delivering optimal results in high-growth environments, through initiatives that exceed operational performance targets and yield measurable outcomes.Specialties: Quality System Design, OSM Off site Manufacturing, Product Development, Production Planning, Forecasting, Account Management, Technical Problem Solving, Regulatory, Auditing, Industrial/Medical Electronics design and servicing, USAR Rescue, Procurement and Fund-raising.