Ms Emma Lester

Quality and Regulatory Manager

Bachelor of Forensic Science (Biology) from Griffith University

Emma Lester is an accomplished quality and regulatory professional with over 15 years of experience in quality management, specialising in Laboratory Developed Tests (LDTs) and Medical Devices.  She has implemented and transitioned multiple Quality Management Systems (QMS) to electronic platforms, ensuring compliance with industry standards. Her expertise includes managing product design and development activities, risk management, verification and validation of new products and process optimization and previous experience of successful FDA 510(k) applications.