About Us
Les Schnoll is the Principal of Quality Docs, LLC and has more than 35 years of experience in quality management, auditing, regulatory compliance, training, submissions, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. His previous positions included several years as corporate Vice President, Quality Assurance and Regulatory Affairs.
Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.
Schnoll has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.
Schnoll’s professional affiliations include the American Society for Quality as a Certified Quality Engineer, Certified Quality Auditor, and Certified Quality Manager; the Regulatory Affairs Professionals Society as Regulatory Affairs Certified; the Institute of Certified Quality Consultants as a Certified Quality Consultant; the American Society for Microbiology as a Registered Microbiologist (clinical microbiology) and Specialist Microbiologist (consumer and industrial microbiology); and the International Register of Certified Auditors as a certified lead assessor. He is a Fellow of the Chartered Quality Institute (formerly the Institute of Quality Assurance), where he obtained certification as a Chartered Quality Professional.
Schnoll is also a member of the United States Technical Advisory Group to Technical Committee 176, International Organization for Standardization and the United States Technical Advisory Group to Technical Committee 210, International Organization for Standardization.
Les has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.
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