Medical Device / Manufacturing Experts
email: timsmith@timsmithconsulting.net

About Me

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Federal Regulatory Experience since 1995, with agencies such as:

  • Departments of Defense, Army, and Air Force
  • United Nations

FDA Experience in Medical Device Since 2004

  • Solid people management and communication skills.
  • Over 20 years of experience leading, training, supervising and mentoring people.
  • Being a Project Lead in the Equipment Engineering, Research and Development, and Process Development groups with an average of 30 projects!
  • 3 to 5 resources per project,managing resources is a big part of what I do every day.
  • As many as 50 projects at one time!
  • A solid knowledge of GMP, ISO regulations, with 23 years of experience in an environment that is regulated.
  • With a wide range of knowledge and experience I would be successful in areas such as manufacturing, validation, research, programming, or control system design.
  • Strong aptitude in electronics, mechanics, software, and along with strong written and verbal communication skills.
  • Phenomenal troubleshooting skills that have been developed over a period of 20 years.
  • Led over 8 million dollars worth of value improvement programs, but more so, I personally pioneered 2 projects that totaled 2 of the 8 million dollars.
  • Six Sigma Green Belt!
  • Nominated for the Cardio Vascular groups “Values” nominee two years in a row (Recognized out of 9,000 individuals as a person with Core Values), and also the Cardio Vascular groups Heart of a Leader Nominee!
  • Awarded with several Quality Initiative awards, Quality Ambassador awards.
  • I hold Quality and Integrity at the core of who I am!
  • Goal-oriented person and a high motivation
  • Traveling or relocation is an option!

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