Bio: Steve Gompertz (CMQ/OE, CMDA, RAC-US, CMII) is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry providing guidance on quality systems and regulatory compliance.
Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. He is a Distinguished Speaker with the Society for Quality Assurance (SQA) and was awarded the 2023 Charles W. Britzius Distinguished Engineer Award by the MN Federation of Engineering, Science, and Technology Societies (MFESTS).
Abstract:
In 1989, Stephen R. Covey published The 7 Habits of Highly Effective People, launching a framework for personal effectiveness that has endured for more than three decades. With over 25 million copies sold and translations into more than 40 languages, Covey’s work resonated because it articulated a universal progression of maturity: from dependence, to independence, to interdependence. While originally framed around personal effectiveness, these same principles translate directly to leadership, particularly within the quality profession.
This presentation applies Covey’s maturity model to the evolution of quality leadership. Just as individuals mature, quality leaders progress through distinct stages. Early-stage quality functions often operate in a control-focused mode, emphasizing enforcement, inspection, and compliance policing. As organizations mature, quality transitions into a management-focused role, characterized by defined processes, metrics, and structured problem solving. True quality leadership, however, emerges when the function operates at an organizational leadership level, influencing strategy, culture, and decision-making across the enterprise. At this stage, quality moves from driving individual or departmental success to enabling sustainable organizational performance.
Achieving this progression is neither accidental nor automatic. It requires the deliberate development of seven habits specific to effective quality leadership. These habits include practicing systems thinking rather than siloed optimization; intentionally shaping and reinforcing a quality culture; making disciplined, data-driven decisions; ensuring requirements are clearly understood and correctly translated into processes and products; proactively preventing issues instead of reacting to failures; communicating in the language of executive leadership, including risk, cost, and business impact; and treating quality not as an administrative function, but as a true profession with defined competencies and ethical responsibilities.
Attendees will leave with a practical leadership lens they can apply immediately, regardless of industry or organizational maturity. This session is designed to help quality professionals assess where they and their organizations currently operate on the control-to-leadership continuum, and to identify concrete steps for advancing both personal effectiveness and organizational impact through the disciplined practice of these seven habits.
Proposed Agenda:
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Introduction
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Leading Without Authority
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Covey’s 7 Habits
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The 7 Habits Applied to Quality Leadership
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Maturity Stages
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Habit 1: It’s a System
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Habit 2: All Hands on Deck
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Habit 3: Don’t Just Monitor, Analyze
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Habit 4: It’s All About Requirements
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Habit 5: Quality Isn’t Accidental
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Habit 6: Show Them the Money
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Habit 7: It’s a Profession, Not a Hobby
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Take-Aways and Q&A
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