Eric Pettes

Eric Pettes is an experienced QMS transformation consultant with over 25 years of experience in medical device, medical consumables, pharmaceutical consumables, and parental drug injectables. He has held VP QA/RA positions for medical device and combination product contract manufacturers as well as medical device OEM’s. Eric has worked for companies including Jabil (Nypro Healthcare), Philips-Medisize, […]

John Nagle

John Nagle is an experienced QMS trainer and consultant with over 30 years of experience in medical device, medical consumables, pharmaceutical consumables, and parental drug injectables, as well over 20 years in the In Vitro Diagnostics industry. He has held positions in companies ranging from 10-20 person startups to multinational companies. John has worked for […]

Alyce Nelson

Alyce Nelson holds a bachelor’s degree in Mechanical Engineering from the University of California, a post grad certification from MIT in Cardiovascular Anatomy & Pathophysiology for Scientists and Engineers, a diploma from the Krieger Institute of Canada in Clinical Research, an Exemplar certification as a Lead Auditor for Medical Devices, and a certification as a […]

Ken Campanale

Ken is a senior executive and educator with experience in global Regulatory Affairs, Clinical Research, Quality Systems, and R&D in the Medical Devices industry. His key accomplishments include implementing new product development processes and design controls within global regulatory requirements and ensuring timely product clearances with FDA and regulatory bodies worldwide. Ken has served as […]

Lori Kahler

Lori Kahler is a highly accomplished professional with over 30 years domestic and international experience in the management of operations, quality, regulatory, and compliance, with proficiency across a full range of business functions and systems, including strategic development and planning, budgeting, business analysis, finance, and information systems.  Lori has successfully directed strategic programs in support […]

Natalya Koshnitsky

Natalya Koshnitsky has served as the Director of Quality Systems and Regulatory Affairs where she successfully designed and implemented a global quality management system and obtained an umbrella ISO 13485 certification for three facilities in the US and Central America. She is highly experienced in all areas of quality management system and compliance, including but […]

Gordon Roberts

Gordon Roberts has over 30 years’ experience in Quality Assurance and Regulatory Affairs at large multi-national corporations such as Smith and Nephew, CR Bard and IBA in addition to setting up quality/regulatory systems at start-up operations such as RadioMed and Uromed Corporation. Gordon is an ASQ certified Quality Manager, Quality Auditor and Biomedical Auditor. He […]

Steven Rakitin

Steven R. Rakitin has over 40 years experience as a software engineer and software quality manager. He has written extensively on the subject of software quality and published a book titled Software Verification & Validation for Practitioners and Managers, 2nd ed. He has worked on several IEEE Software Engineering standards committees and was a member […]

Angelo Scangas

Angelo has more than 35 years of experience in engineering, quality systems, operations and process improvement (Lean Six Sigma) in the Medical Device, Automotive, Aerospace, Consumer, Electronic, Healthcare, and Chemical Industries. His background includes product development, design/process engineering, supply chain management, supplier quality, quality system design and implementation (ISO 9001, ISO 14001, ISO 13485, IATF […]

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