Focus: ensuring quality is built in to every product or service I provide or support and ensuring total customer satisfaction.Company Achievements: * Developed and deployed Quality Management System * Successfully led company to ISO 13485 and ISO 9001 certification * Built and maintained strong V&V teamAchievements for Clients: * Enabled device clearance (FDA 510(k), PMA; EU CE marking). * Deployed Quality Management System enabling certification to ISO 13485 * Led Risk Management efforts compliant to ISO 14971 * Drove software development efforts compliant to IEC 62304 * Drove usability engineering efforts compliant to IEC 62366 * Successful remediation efforts for clients with audit findings / 483s * Managed DHF, DMR, Technical File * Developed and executed verification and validation for medical device products. * Developed and executed validation of (non-product) computer systems * Developed and executed validation of manufacturing processes / equipment.Specialties: Wide and deep experience in product development process including 14971, 62304, 62366.Ability to meld corporate culture with regulatory requirements and defined processes.Knack for rooting out issues and pinpointing root causes.