George has been in leadership and contributor roles in quality, medical device regulation, information technology, software development and delivery, and process improvement for over two decades. George is a Co-founder and Principal at Two Harbors, a firm focused on helping organizations achieve greater business value and performance results above compliance and regulatory expectations. George’s efforts include helping medical device manufacturers connect with FDA CDRH in the Case for Quality’s Voluntary Improvement Program and the budding program for non-compliant device sits seeking to accelerate their process capabilities. George’s experience in process and continuous improvement also includes value stream mapping engagements, Agile and other SDLC transformations, Six Sigma and enterprise tool implementations. George is certified (ASQ) Lead Auditor, a CMMI Professional and a CMMI Lead Appraiser Candidate. Outside of his efforts with Two Harbors, George is a volunteer assistant coach to the local high school cross country and distance running squad, and is active in various roles with the local Scout BSA Troop.