Brian Newbery


Consultant


A seasoned medical device quality system consultant with over two decades of experience in global quality systems and regulations. Expertise spans across medical devices from Class I to Class III, covering all parts of the product life cycle, including design, development, manufacturing, and post-market activities. Focused on helping start-up medical device companies fast-track their quality management systems to achieve certification and assisting with major QMS transitions, such as the FDA QMSR transition.

CORE COMPETENCIES

  • Fast-Track Complete QMS Implementation
  • Use of QMS Documentation Templates
  • Gap Analysis and Implementation Planning
  • ISO 13485:2016 Certification Support
  • QMSR Gap Analysis and Transition Planning
  • QMSR Transition Support
  • Quality System Training and Coaching
  • QMS Remedial Action Support
  • Internal Auditing
  • Process Verification and Validation
  • Corrective and Preventive Action Process (CAPA)
  • Design and Development Compliance
  • Effective Quality Metrics
  • Parametric Release and Improvements in Cost of Quality (CofQ)

SELECTED ACCOMPLISHMENTS

  • Global Leadership and Team Management: Led global quality system teams across North America and Asia, managing quality operations in facilities ranging from small manufacturing plants to sites with over 2,500 employees.
  • Proactive Quality Planning: Initiated, developed and implemented changes from a reactive to proactive quality planning and management approach. This resulted in significant improvements in product quality and reductions in the cost of quality as well as increased customer satisfaction. 
  • ISO Certification Fast-Tracking: Working with start-up medical device facilities fast-tracked QMS implementation and achieved ISO Certification in 6 months.
  • Industry Recognition and Awards: Chairman’s Science and Technology Award, Robotic System, Allegiance, Cardinal Health
  • Patent Achievement: Design Patent Award for Bi-Directional Tractor Design, USA 1993

PROFESSIONAL EXPERIENCE

  • Fast-Track QMS Consultants
    • Founder and Senior Consultant (June 2019 – Present)
  • Cardinal Health
    • Director QA/RA, Rayong, Thailand (Feb. 2003 – May 2019)
  • V. Mueller
    • Senior QRM Manager, St. Louis, MO, USA (Feb. 1998 – Feb. 2003)
  • Ford New Holland
    • QA Manager, Winnipeg, Canada (1993 – 1998)
    • Product Design Leader, Winnipeg, Canada (1990 – 1993)

EDUCATION

  • Higher National Certificate, Mechanical Engineering, Taunton College UK (July 1973)
  • Mechanical Engineering Certificate, London Institute UK (June 1971)

CERTIFICATION

  • Quality System Lead Auditor, General Physics Corporation (March 1995)
  • Implementing a Quality Management System Compliant with ISO 13485 & MDD, TUV (June 2003)
  • Certificate of Management, University of Manitoba (May 1995)
  • Certification of Quality Management, University of Manitoba (May 1997)

TRAINING

  • Lead Auditor Training & Certification, General Physics (March 1995)
  • ISO 13485/MDD QMS Implementation, TUV (June 2003)
  • SPC Tools, Cardinal in-house training (June 2010)
  • Risk Management, Cardinal in-house training (Aug 2010)
  • Design and Process Validation, Cardinal in-house training (April 2012)
  • Lean Six Sigma, Green Belt and Project Sponsor training, Cardinal (June 2012)
  • Concurrent Engineering, Ford New Holland (May 1995)