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. 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 a BS in genetics and 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.
Most recently, she completed Advanced Lead Auditor training with Oriel Stat A Matrix in 2016.