Tracey Cato joined the National Isotope Development Center (NIDC) in March 2026 as the Quality Assurance and Regulatory Affairs Manager. She leads the development and implementation of quality management systems and regulatory compliance strategies to support isotope production and distribution activities.
Tracey brings nearly 30 years of experience in quality assurance, regulatory compliance, and operations across FDA-regulated medical device and biologics manufacturing, as well as CLIA- and CAP-accredited laboratories. She has led the development and enhancement of quality systems across regulated industries, ensuring alignment with complex operational and compliance requirements.
In 2021, Tracey received the Secretary of Energy Achievement Award for her leadership in establishing a CLIA/CAP testing laboratory for COVID-19 surveillance at Oak Ridge National Laboratory (ORNL). She also serves as an ORNL root cause analyst and nuclear quality assurance lead auditor. She maintains ASQ certifications as a Certified Quality Auditor, Certified Quality Process Analyst, and Certified Six Sigma Green Belt.
She holds a Master of Science in Industrial Engineering from the University of Tennessee and a Bachelor of Science in Biology from Kennesaw State University.
