Lezlie Hynes

Lezlie Hynes is a Principal Quality & Software Systems Consultant at MDC Associates, with over 25 years of experience in quality systems compliance. She specializes in FDA, ISO, and international compliance standards for medical devices and IVDs including SaMD and SiMD. Lezlie has extensive experience managing internal and supplier audits, CAPA processes, and implementing Quality Management Systems and eQMS solutions, driving high-quality outcomes for regulatory success.

Lezlie’s expertise spans the entire quality systems lifecycle, from strategic planning to execution, helping clients meet stringent regulatory requirements. Her leadership in quality management has been instrumental in achieving successful FDA inspections and supporting regulatory submissions, ensuring compliance with global healthcare standards.

Lezlie holds a Bachelor of Arts in Medical Technology from the College of St. Scholastica and a MT (ASCP) certification from the American Society for Clinical Pathology. She is also certified as a Quality Auditor (CQA) and Software Quality Engineer (CSQE) by the American Society for Quality (ASQ).