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

David has over 35 years’ experience as a consultant and auditor within several industries such as public utilities, glass production, consumer product printing, metal fabrication, thermal packaging, and medical device. David has led four organizations to ISO9001 certification including ISO13485 and compliance with 21 CFR 820 regulations. He has a special expertise in providing consulting and auditing services for producers of medical devices and pharmaceutical drugs. Some of his clients have included Johnson & Johnson, Merck, Baxter, Janssen, Abbott, Hospira, Samsung Biologics, and Amgen.

David has worked with companies providing medicinal drugs, skin treatment products, dental supplies, precision machining operations, injection molding, diagnostic imaging, inspection, testing and calibration labs, coating and service treatment operations, software developers, warehousing and distribution centers, and transportation of temperature controlled drug products.

As an auditor and consultant, David’s primary focus is to ensure compliance with relevant quality and regulatory standards and to assess the effectiveness of an organization in meeting planned objectives.

David holds a B.S. in Business Administration and an M.A. in Business and Policy Studies from the State University of New York.  He is a senior member of the American Society for Quality (ASQ).  His professional certifications include:

  • Certified Manager of Quality and Organizational Excellence CMQ/OE
  • Certified Six Sigma Black Belt CSSBB
  • Certified Quality Auditor CQA
  • Certified Quality Engineer CQE
  • Exemplar Global – Certified Auditor

Risk Based Thinking

Documentation Practices
PECB certified ISO 9001:2015 Transition
NEQC Certificate of Achievement
ISO13485-2016 Overview



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