Kurtis James
Lead Quality Assurance & Quality Control at US WorldMeds- Claim this Profile
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Bio
Credentials
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Fundamentals of Sustainable Supply Chains
LinkedInJul, 2023- Oct, 2024 -
Root Cause Analysis: Getting to the Root of Business Problems
LinkedInJul, 2023- Oct, 2024 -
Six Sigma Foundations
LinkedInJul, 2023- Oct, 2024 -
Quality Management Foundations
LinkedInJun, 2023- Oct, 2024 -
Quality Management for Operational Excellence
LinkedInJun, 2023- Oct, 2024 -
Certified Quality Auditor (CQA)
American Society for QualityAug, 2023- Oct, 2024 -
Six Sigma Green Belt
Institute of Industrial and Systems Engineers
Experience
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US WorldMeds
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Lead Quality Assurance & Quality Control
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Apr 2022 - Present
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Symmetry Surgical
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Engineer
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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.
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Research Engineer
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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.
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Research Engineer
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Jan 2012 - Sep 2012
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Education
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University of Louisville
Master of Engineering (M.Eng.), Engineering Management -
University of Louisville
Master of Engineering (M.Eng.), Bioengineering -
University of Louisville
Bachelor's degree, Bioengineering