David L. McDonald, Consultant – Quality/Regulatory Systems/ISO 13485/Second Party Audits

David has over 30 years of experience in manufacturing. As a quality manager, David has led three organizations to ISO 9001 certification, including ISO 13485 and compliance with 21 CFR 820 regulations. His background includes managing internal and supplier audits, improving corrective/preventive action systems, implementing balanced scorecards, risk assessment, supply chain management, SPC techniques, customer satisfaction surveys, and cGMP compliance.

As an internal consultant, corporate trainer, and project manager, David’s primary focus is to satisfy customer requirements and achieve positive business results. His project implementations use Lean Six Sigma techniques to improve key performance indicators such as cost savings, cycle time reduction, higher production yields, and improved customer satisfaction.

David is a senior member of the American Society for Quality (ASQ). His professional certifications include CMQ/OE, CSSBB, CQA, CQE, and RABQSA – Auditor.

David holds a B.S. in Business Administration and an M.A. in Business and Policy Studies from the State University of New York.

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