Arghya M.

Medior QARA Engineer at Quest Medical Imaging
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Contact Information
us****@****om
(386) 825-5501
Location
Alkmaar, North Holland, Netherlands, NL
Languages
  • English Native or bilingual proficiency
  • Bengali Native or bilingual proficiency
  • Hindi Professional working proficiency

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Credentials

  • Process Validation for Medical Devices
    TÜV SÜD
    Jul, 2023
    - Sep, 2024
  • ESD Basic Training
    Olympus Surgical Technologies Europe
    Feb, 2023
    - Sep, 2024
  • Implementation of Medical Device Regulation (MDR) for CE marking Training Course
    BSI
    Dec, 2022
    - Sep, 2024
  • Post-market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Devices Regulation (IVDR)
    BSI
    Dec, 2022
    - Sep, 2024
  • ISO 13485:2016 Internal Auditor
    BSI
    Aug, 2021
    - Sep, 2024

Experience

  • Quest Medical Imaging
    • Netherlands
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Medior QARA Engineer
      • Jan 2022 - Present

      Quality Assurance- Production, Operations, Supplier Control.Regulatory Affairs- Regualtion (EU) 2017/745 (EU MDR), FDA, Regulatory Submissions.

    • Quality Engineer
      • Apr 2021 - Dec 2021

      Quality Assurance and Quality Control- ProductionRegulatory Affairs- Regualtion (EU) 2017/745 (EU MDR), FDA

  • i3S - Instituto de Investigação e Inovação em Saúde
    • Portugal
    • Research Services
    • 400 - 500 Employee
    • Graduate Research Intern
      • Sep 2019 - Dec 2019
  • Steel Authority of India Limited
    • Manufacturing
    • 700 & Above Employee
    • Vocational Trainee
      • Jun 2017 - Jul 2017
  • CESC Ltd.
    • United Kingdom
    • Vocational Trainee
      • Dec 2016 - Jan 2017

Education

  • University of Twente
    Master of Science - MS, Biomedical/Medical Engineering
    2018 - 2020
  • Heritage Institute of Technology
    Bachelor of Technology - BTech, Applied Electronics and Instrumentation Engineering
    2014 - 2018
  • South Point High School, Kolkata
    10th and 12th Grade Schooling, Primary, Secondary and Higher Secondary Education
    1999 - 2014

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