David Bucknam – Consultant, Quality & Regulatory Systems

David brings 35 years of experience in operations, engineering and quality systems entirely in the Medical Device Industry with multinationals Johnson and Johnson, Medtronic, CR Bard and Terumo in addition to startups Heartware and Lifeline Sciences.

David’s extensive background includes manufacturing operations, supply chain management, process engineering, supplier quality, product development, quality system management, regulatory compliance, program management and continuous improvement.

David’s consulting expertise includes supporting multinationals Becton Dickinson, Cook Medical and Orchid Orthopedics with EU-MDR, EU-IVDR, MDSAP, Warning Letter Remediation, Quality System Compliance, Corrective and Preventive Action, Production Controls, Facility and Environmental Controls, Equipment Qualification, Process Validation and Preventive Maintenance Software Implementation; and startups Cohero Health and Wellmetrix with Quality System Implementation, Product Development, Design Controls, Sourcing and Supplier Management.

David is a senior member of the Association for Supply Chain Management (ASCM) and the American Society for Quality (ASQ) and has achieved ASCM certification CPIM (Production and Inventory Management), World Class Manufacturing Organization (WCMO) certification Lean Champion, Exemplar Global certificate for ISO 13485 Lead Auditor and Medtronic certificate for Process Validation.

David received a B.S. degree in Industrial Management from the University of Massachusetts-Lowell.

Always Keep Improving!