Tim Krotchko

at MYCO Medical
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Contact Information
us****@****om
(386) 825-5501
Location
Apex, North Carolina, United States, US

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5.0

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Steven Nail

Tim is a very detailed oriented worker that takes pride in what he does. When Tim is tasked with a project, he is determined to apply his knowledge and skills to achieve the best possible outcome for the project that will either meet or exceed the project goals. He is also very thorough with any information conveyed about a particular project and makes sure any relative documented material is corrected within the standards of the organization.

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Credentials

  • Bloodborne Pathogens
    National Health and Safety Association
    Dec, 2020
    - Oct, 2024
  • ISO 13485 Lead Auditor
    Stat O Metrics

Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
      • Jul 2021 - Present

      • Feb 2013 - Jul 2021

      Implementation of an FDA compliant Quality system, while working to maintain and improve product quality through an aggressive supplier development and management program. Responsible for leading the Quality activities at the firm, my team manages Quality compliance through multiple foreign government regulatory agencies, ISO, and US FDA Good Manufacturing Practices as mandated in title 21 of the Federal Food, Drug, and Cosmetic Act.

      • Sep 2010 - Feb 2013

      I was tasked with the implementation of a working Quality System compliant with USFDA regulations for the import and distribution of Class I and Class II medical devices. Serving on the company's Management Team, I was the appointed Management Representative as defined in 21CFR820.20 and continue to serve the company in this capacity.

    • Germany
    • Motor Vehicle Manufacturing
    • 700 & Above Employee
    • Corrective Action Team Member
      • Jul 1996 - May 2009

      Quality Engineering - Lead information technician for Quality and Plant dashboard, assigned to lead process improvement initiatives in the Paint/Coatings unit. Certified ISO 9001/14000 Internal Auditor Certified Corporate Trainer through Learning Point, Inc. Six Sigma Green Belt trained Quality Engineering - Lead information technician for Quality and Plant dashboard, assigned to lead process improvement initiatives in the Paint/Coatings unit. Certified ISO 9001/14000 Internal Auditor Certified Corporate Trainer through Learning Point, Inc. Six Sigma Green Belt trained

Education

  • University of North Carolina at Charlotte
    Bachelor of Creative Arts
  • Rowan Cabarrus Community College
    Associates in Applied Science Degree Program
    2009 - 2011

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