Kurtis James

Lead Quality Assurance & Quality Control at US WorldMeds
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Contact Information
us****@****om
(386) 825-5501
Location
Louisville, Kentucky, United States, US

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Credentials

  • Fundamentals of Sustainable Supply Chains
    LinkedIn
    Jul, 2023
    - Oct, 2024
  • Root Cause Analysis: Getting to the Root of Business Problems
    LinkedIn
    Jul, 2023
    - Oct, 2024
  • Six Sigma Foundations
    LinkedIn
    Jul, 2023
    - Oct, 2024
  • Quality Management Foundations
    LinkedIn
    Jun, 2023
    - Oct, 2024
  • Quality Management for Operational Excellence
    LinkedIn
    Jun, 2023
    - Oct, 2024
  • Certified Quality Auditor (CQA)
    American Society for Quality
    Aug, 2023
    - Oct, 2024
  • Six Sigma Green Belt
    Institute of Industrial and Systems Engineers

Experience

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Lead Quality Assurance & Quality Control
      • Apr 2022 - Present

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Engineer
      • Feb 2018 - Apr 2022

      Responsible for providing Quality oversight of Facilities and Equipment Quality Management Systems (QMS) to ensure compliance with applicable US/MDSAP regulations, industry standards and internal policies/procedures supporting GMP manufacturing of surgical product. Track, trend, and analyze quality metrics for continuous improvement efforts. Lead investigation of customer complaints that lead to a resolution with customer. Responsible for providing Quality oversight of Facilities and Equipment Quality Management Systems (QMS) to ensure compliance with applicable US/MDSAP regulations, industry standards and internal policies/procedures supporting GMP manufacturing of surgical product. Track, trend, and analyze quality metrics for continuous improvement efforts. Lead investigation of customer complaints that lead to a resolution with customer.

    • Research Engineer
      • May 2013 - Feb 2018

      Responsibilities include designing, testing, characterizing, and recording results on studies involving nanoparticles, drugs, and animal models. Work in teams across multiple fields/departments of research to achieve project goals, deadlines, and ensure validity. Responsibilities include designing, testing, characterizing, and recording results on studies involving nanoparticles, drugs, and animal models. Work in teams across multiple fields/departments of research to achieve project goals, deadlines, and ensure validity.

    • Research Engineer
      • Jan 2012 - Sep 2012

Education

  • University of Louisville
    Master of Engineering (M.Eng.), Engineering Management
    2016 - 2017
  • University of Louisville
    Master of Engineering (M.Eng.), Bioengineering
    2012 - 2013
  • University of Louisville
    Bachelor's degree, Bioengineering
    2007 - 2012

Community

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