OUR VISION
New England-based medical technology & life sciences organizations, as well as their key suppliers, achieving high levels of quality and performance through adoption of best-in-class quality management practices.
OUR MISSION
To enable local medical technology organizations
to leverage their quality management systems
as sources of competitive advantage
while ensuring product/service safety and effectiveness and
compliance with all applicable regulations and standards.
VALUES
CLIENT FOCUS, COLLABORATION, ADAPTABILITY, CREATIVITY, INTEGRITY
LEADERSHIP
FRANK DeFAZIO: Founder, Principal, & Executive Director
Frank has over 20 years of experience Leading Change and Driving Quality, Compliance, Innovation, and Improvement across diverse Functions, Levels, Reporting Structures, Cultures, and Geographies in the Medical Technology/Life Sciences Industry. He has over 25 years of multi-industry work experience in start-ups to large multinationals.
Frank has held leadership positions at Corporate, Business Unit, Divisional, and Site levels at Medtronic, Covidien, LabCorp/Genzyme Genetics, Genzyme, and Mosaic Technologies. He has also provided consulting services to diverse medical technology/life sciences companies: from small to mid-size to global corporations with product offerings in areas such as diagnostics, home-based therapies, instrumentation, wearables, and software.
Frank has been on both sides of acquisitions and his project management and functional management experience ranges as follows:
-
Project Management: Leading QMS strategy and development, compliance-readiness, quality system (both process and technology) integration, process improvement, business excellence initiatives, new product development, transformation programs, information technology implementations, sustaining engineering, and site risk remediation.
-
Functional Management: Leading local to global departments across Quality Assurance, Regulatory Affairs, and PMO.
Throughout his career, Frank has consistently delivered:
-
Increases in Customer Satisfaction, Productivity, On-Time Launches/Go-Live, and Compliance.
-
Decreases in Unacceptable Risks, Process Cycle Times, Time-to-Market, Errors, Rework, and Costs.
Frank earned a certificate in Disruptive Strategy from HBX-Harvard Business School, has held certifications in quality, compliance, and regulatory affairs (including RAPS-RAC and ASQ-CMQ/OE), completed graduate studies in Management at Boston University and Six Sigma Black Belt training with ASQ, and has a Bachelor’s degree from the University of Massachusetts at Boston.
