Dave Gaspar Email & Phone Number

Results oriented quality management professional with 24+ years of progressive Medical Device and Quality Management Systems experience in both domestic and international markets, including effective quality system management and development of strategic supplier partners across supply chain.Extensive experience and expertise of ISO 13485, ISO 9001 & ISO 14001 implementation. Knowledgeable of 21 CFR Part 820 QSR, 21 CFR Part 54 GLP, EU Medical Device Regulation (MDR) 2017/745, Medical Device Directive, ISO 14971, MDSAP, ANVISA, TGA, and ISO 11135 in support of regulated highly complex systems devoted to the design, development and production of medical devices whose purpose is to improve the quality of life and surgical outcomes. Successful background as a team leader with the ability to manage, mentor, multi-task, and perform well under pressure and effectively influence and add value to both internal and external stakeholders. Exceptional internal and external auditing, analytical, organizational, interpersonal, problem solving, and team building skills.

Listed skills include Quality System, Iso 13485, Medical Devices, Fda, and 28 others.