Debra Roark MacRae

Debra Roark Macrae has a strong background in quality management and auditing. Debra has extensive experience in creating and implementing quality management systems, ensuring compliance with regulatory requirements. Debra has held leadership roles in various companies, including LumiThera, MarqMetrix Inc., HealthFirst, Physio-Control, Atossa Genetics, Flextronics Medical, Miraca Life Sciences, and Abbott Laboratories - Diagnostic Division. Throughout their career, they have successfully obtained ISO certifications and managed external regulatory agency inspections. Debra has also played key roles in cross-functional project teams, overseeing quality activities for medical device development and ensuring compliance with FDA and ISO standards. Debra'sexpertise includes managing quality activities for diagnostic equipment, software, and hardware design control.

Debra Roark Macrae pursued their education in a chronological manner, starting with a Bachelor of Science (BS) degree in Laboratory Technology from the University of Oklahoma, which they obtained between 1983 and 1986. Debra later attended the University of North Texas from 1993 to 1996, where they obtained a Master of Science (MS) degree in Biology, specializing in Immunology.

In addition to their formal education, Debra has also acquired several certifications to enhance their professional skills. Debra obtained a Quality Auditor certification from the American Society for Quality in December 2006. In October 2010, they obtained an FDA QSR and Industry Practice certification from the American Association for Medical Instrumentation. In November 2011, Debra earned the Six Sigma Black Belt certification from the American Society for Quality.

Although no specific information is provided regarding their Medical Technologist certification, it is mentioned that Debra is certified as a Medical Technologist by the American Society for Clinical Pathologists.