Self-starting, strategic thinker recognized as a subject matter expert in Medical Device Quality Management Systems including Risk Management, Design and Development, Management Responsibilities and Improvement. Specific experience includes audit and submissions to comply with US QSR (21CFR820), ISO 13485, Canadian Medical Device Regulations (CMDR/CMDCAS), Medical Device Directive (MDD), In-vitro Diagnostic Directive (IVDD), Japan Pharmaceutical Affairs Law (JPAL), Therapeutic Goods Act (TGA), Brazilian regulations (ANVISA) including the Medical Device Single Audit Program (MDSAP). Extensive career experience throughout the product life cycle for all classes of medical devices and drug combination devices from concept through development to product release and post-market support. Solid reputation for maintaining a firm grasp of project details while also keeping the big picture in focus. Quality Systems--Quality Systems expert participating member with ISO TC210, WG1 on next revision of ISO13485. Recognized subject matter expert for Medical Device Product Risk Management (ISO 14971). Called on by senior management to integrate the quality systems of acquisitions and remediate notified body audit major non-conformance as well as provide direct support and auditor interface for numerous audit/inspections (including FDA, EU certification/notified bodies and other competent authorities (ANVISA, TGA, etc.). Operations--Served as the area quality assurance leader and a site mentor for the Corrective/Preventive Action (CAPA) program. Supervised all quality group responsibilities for facility electronics manufacturing area with several direct and indirect reports. Design/Development--Lead Design Assurance team member from concept through design development and into post market support for several next generation products and new product lines. Participated in supplier selection and led audits for supplier qualification.