Emily Magazzi has a BS in genetics. She has experience with establishing compliance through evaluation and modification of existing ISO 13485 & FDA quality system elements and with auditing to assess suitability and effectiveness of quality management systems.
She has over a decade of experience in FDA, CMDR, and ISO 13485 compliant industries. She has developed and authored quality system documentation in regulated environments, coordinated activity to obtain Canadian registration, assembled new technical files, and maintained numerous other technical files.
She completed Risk Management Training with a focus on ISO 14971 and FDA requirements through Emergo Group with Rai Chowdhary as the instructor. She also completed Risk Management and Design Control training sessions by Noblitt & Rueland which covered FDA and ISO requirements, Advanced Lead Auditor training with Oriel Stat A Matrix and Lead Auditor training in ISO 13485:2016 and FDA requirements with Axeon in 2016, and most recently, she completed Internal Auditor training in MDSAP & ISO 13485:2016 also with Axeon in 2017.
Emily is a certified quality auditor through the American Society for Quality (certification number 45700) and Regulatory Affairs Certified (RAC) by Regulatory Affairs Professionals Society.