Kay Smith

QA Specialist

Kay is a quality assurance professional with nearly 10 years of experience establishing and monitoring quality assurance programs in pharmaceutical, blood banking, and hospital settings. She holds certifications through the American Society of Quality (ASQ) as a Quality Auditor and as a Six Sigma Green Belt. In her previous roles, Kay has provided technical oversight of corporate quality management systems and ensured compliance with federal regulations and client requirements, including numerous regulatory agencies (FDA, AABB, CMS, CAP, CLIA, DEA). She has led/contributed to over 40 successful internal and external company audits, worked with interconnected departments to create and implement standard operating procedures, and developed solutions for benchmarking severity and variance analysis.

Kay is committed to driving Modus Outcomes forward with innovative quality management systems and highly effective policies that will ensure the delivery of high-standard services to meet client needs and requirements. Her diverse background equips her with the knowledge and techniques needed to properly identify and eliminate errors and assess areas for improvement in operational procedures. It also enables her to translate complex requirements and regulations into specifications by integrating knowledge with research.

Kay holds an MS in Biological Sciences with a Pre-Health specialization from the University of Houston Clear Lake and an MBA at Texas A&M University.