Arie Henkin

Arie Henkin has over 10 years of experience in the medical device industry. In 2010, they began their career as a Manufacturing Quality Engineering Intern and Mechanical Manufacturing Engineering Intern at Hologic. Arie then worked as a Quality Engineer and Document Control Coordinator at Tornado Spectral Systems from 2012 to 2013. From 2013 to 2018, they worked at Synaptive Medical, first as a Quality Engineer, then as Quality Systems Manager, and finally as Quality Management Systems Lead. In 2018, they moved to TÜV SÜD as Manager, Certification Body - Medical Health Services. From 2019 to 2021, they worked at Pillar Biosciences Incorporated as Director, QA, RA, Operations, Senior Manager, QA, RA, Operations, and Senior Manager, QA/RA. Since 2021, they have been working at Omniscient Neurotechnology (o8t) as VP, Quality and Regulatory and Head of QA/RA, and also founded Mithril Medical Consulting as Founder / Principal Consultant.

Arie Henkin received a Bachelor of Applied Science (B.A.Sc.) in Mechanical Engineering from the University of Toronto between 2007 and 2012. Arie also holds several certifications, including ISO 9001:2015 Lead Auditor (Exemplar Global) from AQS Solutions, a DEKRA Company obtained in April 2018, ISO 13485:2016 Internal Auditor (Exemplar Global) from BSI obtained in July 2016, P.Eng. from Professional Engineers Ontario obtained in June 2016, Lead Auditor (Exemplar Global) from BSI obtained in January 2014, and Certified Quality Engineer (CQE) from ASQ - World Headquarters obtained in December 2017.