Katherine Mirabella LSSGB, CQPA

Technical File Reviewer at DEKRA North America
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Tampa Bay Area
Languages
  • Spanish Limited working proficiency
  • English Native or bilingual proficiency

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Bio

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Credentials

  • Introduction to Software for Medical Devices and IEC 62304
    medicaldeviceHQ
    Apr, 2022
    - Nov, 2024
  • Certified Quality Process Analyst
    ASQ - World Headquarters
    Apr, 2018
    - Nov, 2024
  • Lean Six Sigma Green Belt Certificate
    Purdue University
    May, 2017
    - Nov, 2024

Experience

    • Public Safety
    • 100 - 200 Employee
    • Technical File Reviewer
      • May 2023 - Present

    • United States
    • Biotechnology Research
    • 200 - 300 Employee
    • Quality Engineer II
      • Sep 2021 - May 2023

    • Quality Engineer I
      • Dec 2019 - Sep 2021

    • United States
    • Medical Equipment Manufacturing
    • 400 - 500 Employee
    • Quality Process Engineer
      • Nov 2018 - Dec 2019

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Associate
      • Dec 2017 - Nov 2018

    • Regulatory Affairs Temp
      • May 2017 - Dec 2017

    • Clinical Engineering Intern
      • Nov 2016 - May 2017

      Managed assigned projects within the Biomed Department, and reported to the Clinical Engineering staff . Collaborated and participated in conference calls and in-person meetings with other interns, biomedical staff, internal VA personnel from different departments, and external contractors and vendors. Experienced with Outlook, SharePoint, Adobe Acrobat, Architectural floor plans, and participating in clinic or project walk-throughs. Extensive exposure to formatting and managing data in… Show more Managed assigned projects within the Biomed Department, and reported to the Clinical Engineering staff . Collaborated and participated in conference calls and in-person meetings with other interns, biomedical staff, internal VA personnel from different departments, and external contractors and vendors. Experienced with Outlook, SharePoint, Adobe Acrobat, Architectural floor plans, and participating in clinic or project walk-throughs. Extensive exposure to formatting and managing data in Microsoft Excel. Show less Managed assigned projects within the Biomed Department, and reported to the Clinical Engineering staff . Collaborated and participated in conference calls and in-person meetings with other interns, biomedical staff, internal VA personnel from different departments, and external contractors and vendors. Experienced with Outlook, SharePoint, Adobe Acrobat, Architectural floor plans, and participating in clinic or project walk-throughs. Extensive exposure to formatting and managing data in… Show more Managed assigned projects within the Biomed Department, and reported to the Clinical Engineering staff . Collaborated and participated in conference calls and in-person meetings with other interns, biomedical staff, internal VA personnel from different departments, and external contractors and vendors. Experienced with Outlook, SharePoint, Adobe Acrobat, Architectural floor plans, and participating in clinic or project walk-throughs. Extensive exposure to formatting and managing data in Microsoft Excel. Show less

    • Research Assistant
      • Jan 2015 - May 2016

      Histomorphometric analysis of murine cervices to determine the role of extracellular matrix constituents in preterm labor. Histomorphometric analysis of murine cervices to determine the role of extracellular matrix constituents in preterm labor.

Education

  • Tulane University
    Engineer’s Degree, Biomedical Engineering
    2013 - 2017
  • Peddie School
    High School Degree
    2009 - 2013

Community

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