Michelle Engle is a seasoned professional with extensive experience in quality assurance and regulatory affairs within the medical device industry. Currently serving as the Director of Quality Assurance and Regulatory Affairs at Medical Murray since May 2015, Michelle has been instrumental in ensuring compliance with ISO 13485, ISO 17025, and FDA regulations. Previous roles included Quality Assurance and Regulatory Affairs Manager and Quality Manager, where responsibilities ranged from managing the quality management system and conducting audits, to overseeing supplier qualification processes and training employees. Prior experience at Klesney-Tait Laboratory involved data analysis and laboratory management, culminating in a published research paper. Michelle holds a Bachelor's Degree in Science and Engineering, specializing in Biomedical Engineering from the University of Iowa.
Sign up to view 0 direct reports
Get started