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Mike Baca

Lead Consultant, Global Quality Systems and Compliance

A lead consultant at MIS Fractional and the President of White Rook Consulting, LLC, brings 36 years of experience in the Medical Device Industry, with leadership roles at Johnson & Johnson, Medtronic, and Stryker. A graduate of the United States Military Academy at West Point, he specializes in global quality systems and regulatory compliance for Class I, II, and III FDA (21 CFR Part 820) and ISO 13485 regulated devices. Mike has led over a dozen FDA inspections, resolved FDA Warning Letters, supported a business unit in an FDA criminal investigation, and provided testimony in product liability cases. His awards include the Medtronic Star of Excellence, Ethicon National Quality Award, and Stryker Instruments Lifetime Master Achiever Award for Quality Excellence. At MIS Fractional, Mike supports MedTech OEMs and contract manufacturers by ensuring compliance and optimizing quality systems for global operations. His consulting services include:

  • Global Quality Systems Implementation and Improvement: Consulting on the implementation and enhancement of medical device quality systems compliant with FDA (21 CFR Part 820) and ISO 13485, ensuring robust and scalable processes.
  • Multi-Plant and Multi-National Quality Operations: Strategies for managing quality operations across multiple plants and international facilities, ensuring consistency, compliance, and operational efficiency for Class I, II, and III devices.
  • Risk Management Principles Application: Application of ISO 14971 Risk Management Principles to identify, assess, and mitigate risks in medical device development and manufacturing.
  • Global Compliance Strategy: Guidance on achieving and maintaining compliance with FDA (21 CFR Part 820) and ISO 13485 standards across global operations, focusing on strategic alignment and scalability.
  • Quality Systems Change Management: Expertise in leading change management initiatives to align quality systems with evolving regulatory and operational requirements, leveraging insights from Risk Management and Design Controls certifications.
  • Certifications: Certified in Risk Management and Design Controls in Greenlight Guru, reflecting his expertise in applying industry-standard tools to enhance quality and compliance. Process Excellence Green Belt and Malcolm Baldridge assessor through Johnson & Johnson. 
  • Due diligence and integration of acquired or merged business units.