Sharon McIlwaineSharon McIlwaine
Chief Operating Officer

As the Chief Operating Officer, Sharon balances Indigo BioSystem’s corporate responsibility of meeting and maintaining regulatory compliance while remaining operationally agile to meet the client’s needs. Sharon has extensive experience as a change agent within all organizational levels, guiding and motivating high-performance teams to re-engineer operational and commercial processes to meet strategic initiatives.

Sharon served as the Director of Competitive Excellence at Ventana Medical Systems and the Director of Continuous Improvement at Roche Diagnostics within the Quality and Regulatory organizations of those two medical device companies. While in those roles, Sharon led site deployments of Lean Sigma for continuous improvement. Her experience also included Quality System changes to improve regulatory compliance as well as participation in FDA audits. As a Certified Six Sigma Black Belt, Sharon served as an internal consultant at the Center for Applied Systems Engineering within the Veterans Administration’s (VA) Veterans Engineering Resource Center. While there, she nationally trained and mentored select candidates on the application of Lean Six Sigma within the VA and led teams in initiatives to redesign major national processes. Sharon’s regulatory expertise includes the Malcolm Baldrige National Quality Award criteria and a Certified ISO Lead Auditor. Using the criteria for the Arizona Quality Alliance, Sharon served as a Lead Judge, where she led a team in the evaluation of processes for hospitals and universities across Arizona.

Sharon is a graduate from the College of Engineering at Bradley University and also received her MBA from the Executive Management program at the University of Arizona.