Katherine Mirabella LSSGB, CQPA
Technical File Reviewer at DEKRA North America- Claim this Profile
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Spanish Limited working proficiency
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English Native or bilingual proficiency
Topline Score
Bio
Credentials
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Introduction to Software for Medical Devices and IEC 62304
medicaldeviceHQApr, 2022- Nov, 2024 -
Certified Quality Process Analyst
ASQ - World HeadquartersApr, 2018- Nov, 2024 -
Lean Six Sigma Green Belt Certificate
Purdue UniversityMay, 2017- Nov, 2024
Experience
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DEKRA North America
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Public Safety
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100 - 200 Employee
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Technical File Reviewer
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May 2023 - Present
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axogen
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United States
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Biotechnology Research
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200 - 300 Employee
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Quality Engineer II
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Sep 2021 - May 2023
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Quality Engineer I
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Dec 2019 - Sep 2021
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Stryker's Sustainability Solutions
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United States
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Medical Equipment Manufacturing
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400 - 500 Employee
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Quality Process Engineer
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Nov 2018 - Dec 2019
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CONMED Corporation
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Regulatory Affairs Associate
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Dec 2017 - Nov 2018
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Regulatory Affairs Temp
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May 2017 - Dec 2017
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Southeast Louisiana Veterans Health Care System Federal Credit Union
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Greater New Orleans Area
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Clinical Engineering Intern
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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
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Biomechanics of Growth & Remodeling Laboratory
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New Orleans, Louisiana
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Research Assistant
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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.
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Education
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Tulane University
Engineer’s Degree, Biomedical Engineering -
Peddie School
High School Degree