Michael D. Baca, president of White Rook Consulting LLC, brings more than 35 years of deep industry insight to the field of medical device quality systems. A proven expert in quality and regulatory affairs, Mr. Baca specializes in Quality Systems, risk management and product development for FDA- and ISO-regulated Class I, II, and III devices. His leadership has helped shape quality standards for some of the industry’s most recognized medical technology companies.

After graduating from the U.S. Military Academy at West Point with a Bachelor of Science in engineering and a minor in mathematics, Mr. Baca embarked on a multifaceted career that included nearly two decades of military service with the U.S. Army and Army Reserve. He transitioned into the medical device industry in 1981, going on to hold executive positions at global leaders including Johnson & Johnson, Medtronic, and Stryker Instruments.

In 2019, Mr. Baca founded White Rook Consulting LLC, where he now provides strategic guidance to medical device companies navigating complex regulatory environments. His expertise includes multinational quality operations, regulatory compliance, design control, and risk management.

Throughout his career, Mr. Baca has been recognized for his impact on quality excellence, earning the Star of Excellence Award from Medtronic and two distinguished honors from Stryker Instruments: the Lifetime Master Achiever Award and the Lifetime Legacy Award for Regulatory Affairs and Clinical Sciences. He also received the Junipero Serra Award from the Society of Hispanic Professional Engineers, honoring his contributions to advancing diversity and excellence in engineering.

Mr. Baca holds multiple professional certifications, including Malcolm Baldridge criteria assessor, process excellence green belt, and quality engineer. He was a longtime member of the American Society for Quality.

Looking ahead, Mr. Baca is committed to mentoring the next generation of regulatory professionals, sharing his knowledge and experience to help them succeed in a highly regulated, mission-critical industry. His legacy is one of discipline, innovation, and a lifelong dedication to quality.