Quality Management Representative
As Management Representative, Guy supports and maintains Archimedic’s Quality System to ensure compliance with ISO standards and FDA’s Quality System Regulations.
Guy’s background and experience cover more than 5 years in the medical device industry specializing in Quality Systems Management. His previous experience includes a contractor position at T2Biosytems as a Software Quality Assurance Engineer.
Guy has been trained on Risk Management covering the USA and European requirements, 21 CFR 820 quality system regulations (QSR), and 93/42/EEC Medical Device Directive (MDD). He is also a trained internal auditor for Medical Device regulations including ISO 13485:2016, and ISO19011:2018)
Guy received a Bachelor of Science in Mechanical Engineering from Northeastern University.