Experienced Medical Device Quality & Operations leader with excellent compliance record with regulatory bodies. A natural leader capable of building world class teams by bringing in the right talent into the organization and developing existing talent within the organization. A leader who can transform company’s quality vision into reality by imbibing a quality culture throughout the organization by encouraging accountability top down and coaching as needed. Equip the team to meet aggressive goals by establishing partnerships with internal and external customers and using motivational strategies customized to the person. Empower the team to take calculated risks and take ownership for their actions.Specialties: Medical Devices • Quality System Design & Deployment • Strategic Decision Making • ISO13485 & QSR Operational Compliance • CE Mark • Risk Management • EU MDR • Program Management • Product Labeling & Localization • MDSAP • Internal & External Audits • Post Market Surveillance • People Management • EN ISO 13485 • EN ISO 14971 • Computer System Validation and Implementation • Software Integrated Systems • Operational Excellence • Lean Manufacturing