Eric Pettes

Consultant, Quality/Regulatory Systems

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, Hologic and Bose, where he led their entry into Medical Device arena with the launch of the world’s first over-the-counter hearing aid.

Eric’s experience encompasses capital equipment, software/SaMD, combination products such as injectors/inhalers, surgical equipment, and consumables/disposable products. He specializes in helping small companies create/upgrade their quality systems, become FDA/ISO audit ready and Establishment Registration ready. Eric has significant experience managing FDA Inspections, and in writing and responding to FDA 483 Inspection Observations. Eric has successfully managed many ISO 13485 transformation/certification initiatives in North America, Europe, and Asia-Pacific helping consumer-based companies make the transition to medical device.

Eric received a B.S. in Business Administration from the University of New Haven, an M.S. in Organizational Leadership and Quality from Marion College and an M.S. in Psychology from the University of Phoenix.

ISO 13485:2016 Lead Auditor

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