About
35+ years at the intersection of quality, compliance, and real-world problem solving
When a quality system fails, the consequences are not abstract. Products reach patients that should not have. FDA arrives. Warning letters follow. Companies that were growing find themselves defending their right to operate. The organizations that navigate those situations well almost always have one thing in common: someone in the room who has been there before.
The Foundation
My quality career did not begin in a regulated industry. It began at Procter and Gamble, where I spent five years in production management and industrial engineering. P&G in the late 1980s was deeply committed to W. Edwards Deming's principles of total quality management and statistical process control, and I became part of the internal cadre of trainers introducing those concepts to 2,500 employees. I was also trained in the Kepner-Tregoe structured problem-solving methodology, a framework that has shaped how I approach root cause analysis and process improvement ever since. I began learning process validation there, analyzed complaint data to drive process improvement, and developed the leadership and coaching skills that P&G was famous for building in its people. Nearly everything I do in quality work today traces a line back to those early years.
Into Regulated Industry
From P&G my career moved into FDA-regulated environments, first at Eli Lilly where I helped write standard operating procedures for engineering change control and process validation, became a trainer in both disciplines, and developed specialized knowledge in controlled environments including cleanrooms, sterilization processes, high-purity water systems, and other utilities supporting aseptic production operations. From there I moved to a contract medical device company, my first formal quality leadership role, where I held broad responsibility across product development QA, production QA and QC, and post-market quality. I experienced my first FDA inspection there, my first recall investigation, and my first taste of covering Director-level quality and regulatory responsibility. Those years built the technical and regulatory foundation for everything that followed.
3M Health Care & Terumo Cardiovascular Systems
In 1998 I joined 3M Health Care in Ann Arbor, Michigan, as Product Assurance Manager, leading a team of quality engineers covering product development QA, production QA, and post-market quality. The following year the business was acquired by Terumo Corporation and became the headquarters of Terumo Cardiovascular Systems. I stayed for fourteen years, the longest chapter of my career, and the one that shaped the enforcement expertise I bring to clients today.
My responsibilities grew steadily through that period, covering quality and compliance leadership across manufacturing operations, supplier management, complaint handling, and post-market surveillance. In my final years at Terumo CVS I moved into a corporate compliance role, responsible for managing compliance auditing and supporting the quality and regulatory functions across four Terumo CVS manufacturing facilities in the United States. That enterprise-level perspective, gained from overseeing compliance across multiple sites simultaneously, is something I bring directly to multi-site consulting engagements today.
A Detour Worth Taking
As I was preparing to leave Terumo and launch into independent consulting, an unexpected opportunity came my way. A small medical device company was navigating a critical period of serious FDA scrutiny and needed experienced quality and regulatory leadership. While it was not as lucrative as the consulting practice I was planning to launch, it offered something more valuable: the chance to take on a significant leadership challenge that would test and expand everything I had built over the previous two decades. I took it.
Working directly alongside the CEO, I led the quality and regulatory function through that critical period, putting the company on a course of sustained improvement that carried on after I left. The CEO credited that work as the foundation for the company's return to growth. It was one of the most challenging engagements of my career and one of the most rewarding. It topped off my experience in exactly the way I had hoped and positioned me well for the consulting work that followed.
Consulting
My consulting career began in 2013, working through an established quality consulting firm on medical device and pharmaceutical engagements. In 2024 I founded Gulf Coast Quality Consulting LLC to build an independent practice and serve clients directly.
FDA Experience
Over the course of my career, I have accumulated more than 125 FDA inspection days across medical device and pharmaceutical manufacturing environments, roughly half of them as the lead in the inspection room and most of the remainder leading the back room operation. I have worked through two consent decree environments, responded to multiple Warning Letters and significant 483 observations, and managed more than forty product recalls.
That depth of enforcement experience was not incidental. It accumulated through sustained leadership roles during periods of serious FDA scrutiny, working alongside legal counsel, outside consultants, and FDA directly over extended periods. I have been in front of FDA in the inspection room, in district office meetings, and at the negotiating table. I understand how FDA thinks, what it looks for, and what it takes to satisfy it.
What I Bring
Quality work, done well, is fundamentally an engineering discipline. You identify the system, understand how it fails, find the root cause, and fix it in a way that holds. That problem-solving orientation, grounded in a BS in Mechanical Engineering from Rose-Hulman Institute of Technology and sharpened over four decades of hands-on work, is what I bring to every engagement, whether it is a QMS build, an inspection response, or a remediation effort under FDA scrutiny.
Credentials
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Exemplar Global Certified Lead Auditor, Quality Management System
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BS, Mechanical Engineering, Rose-Hulman Institute of Technology
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American Society for Quality, member for 30+ years, active mentor
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35+ years in medical device and pharmaceutical quality and regulatory compliance
Availability
Gulf Coast Quality Consulting is available for engagements across the United States and internationally, on-site, remote, or hybrid.
Ready to Talk?
Reach out to schedule a complimentary consultation and discuss how Gulf Coast Quality Consulting can help.
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