Dave Gaspar

About Dave Gaspar

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 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.

Experience

1. Senior Compliance Manager, Internal Audit

   Olympus Corporation

   Feb 2012 — Present

Education

• Bryant University

  MBA, Management of Operations & Technology

  1993 — 1994

• University of Massachusetts Dartmouth

  BS, Management

  1989 — 1993

Skills

• 21 Cfr Part 820
• Quality Assurance Agreements
• Cqa
• Iso 14001
• Product Development
• Root Cause Analysis
• Quality Assurance
• Design Control
• Asq Cmq/Oe
• Team Building
• Asq Cba
• Fda Gmp
• Fda
• Responsible
• Medical Devices
• Capa
• Strategic
• Quality System
• Asq Cqa
• Cross-Functional Team Leadership
• Supplier Quality
• Iso 14971
• Glp
• Arranger
• Iso 13485
• Learner
• Product Launch
• Quality Auditing
• Achiever
• Asq Senior Member
• Regulatory Requirements
• Asq Cqe