Mark Crooks, MBA is a certified Six Sigma Green Belt with more than 30 years of professional quality assurance experience in the medical diagnostic and pharmaceutical industries. He offers expertise and leadership in process improvement, regulatory compliance, quality system design, validation, design control, GMP/GLP, CAPA programs and supply chain management. Additionally, Mr. Crooks is a qualified internal and external auditor with experience in FDA and ISO quality system regulations (including ISO 13485 and 14971). As the Quality Assurance Branch Manager for MiraVista Diagnostics, Mr. Crooks is responsible for ensuring company-wide compliance with multiple regulatory agencies, including FDA, ISO and CLIA as well as adherence to internal quality policies, standard operating procedures and best practices. This includes architecting and managing quality-focused processes, tracking quality through key performance indicators (KPI), developing and maintaining process documentation, facilitating vendor and customer supply chain activities, and administering change control and CAPA programs for the company’s clinical laboratory, research and development and production departments.
Prior to joining MiraVista, Mr. Crooks served in a series of quality assurance and quality engineering positions for large pharmaceutical and medical device manufacturing organizations. Through his career, he has developed deep expertise in process evaluation, quality audits, root cause analysis, continuous improvement, engineering change controls, validation systems, regulatory compliance, training programs and project management. His professional contributions have resulted in measurable improvements in operational, production and supply chain efficiencies, conformance, resource allocation, waste reduction and cost control.
Mr. Crooks graduated from Butler University in Indianapolis with a Master of Business Administration (MBA) degree and earned a Bachelor of Science degree in chemistry from Indiana University in Bloomington, IN. Additionally, he has completed advanced training in RAB auditing, Good Manufacturing Practices (GMP), process improvement and FDA recalls.