Medical Device Auditor 9

The auditor, based in Toronto, Ontario, Canada, holds certifications in ISO 13485:2016 and ISO 9001:2015. They specialize in Quality Assurance & Regulatory Affairs (QARA), demonstrating expertise in FDA 21 CFR Part 820, EU-MDR 2017/745, and HC MDR compliance. Skilled in complaints handling, CAPA system coordination, and eQMS software management, they ensure regulatory adherence and drive process improvement. With a Master's in Mechanical Engineering from the University of Ottawa and a Bachelor's from the University of Engineering & Technology in Lahore, Pakistan, the auditor brings a strong academic foundation to their professional role.