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Anastasia Latoshko profile image

Anastasia Latoshko

Quality Assurance Engineer at BrainQ Technologies
Intro Book
Quality assurance expert with 10+ years of experience in implementing and managing quality management systems for medical devices.
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Location
Israel, IL
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Anastasia Latoshko is a seasoned quality assurance professional with 10+ years of experience in implementing and managing quality management systems for multi-disciplinary medical devices, ensuring compliance with regulatory standards such as 21 CFR Part 820 and ISO 13485. She has a strong educational background in life science and business administration from The Hebrew University of Jerusalem and Hadassah Academic College.

Experience

  • BrainQ Technologies
    • Quality Assurance Engineer
      • Aug 2022 - Present

      Implementation and management of Quality Management System in compliance with 21 CFR Part 820 and ISO 13485 and MDR for multi-disciplinary medical devices, including electromechanical parts, software and cloud.Lead quality system processes, such as ECO, CAPA, MRB, NC, customer complaints and training.Write and implement company procedures and list of standards.Providing Quality Management System support to all company activities, design and development, testing and manufacturing.Support regulatory submissions of new products or changes to existing product.Prepare and maintain technical files and general safety and performance requirements.Support Risk Management activities.Support manufacturing activities.

  • Phibro Animal Health
    • QA Specialist
      • May 2017 - Apr 2022

      -Ensuring compliance with GMP at the QC and R&D departments.-Ensuring compliance with GLP at the R&D trials.-Participating, Conducting, managing and writing risk assessments .-Vendor`s qualification of raw materials .-Reviewing and qualifying IQ, OQ and PQ of HVAC and water (PW/WFI) systems.- Annual review writing for PW/WFI and HVAC systems.- Conducting internal audits.- Conducting external vendor audits.- Reviewing and approving protocols, validations, trials and follow-up reports.

  • Omrix Biopharmaceuticals
    • Jerusalem Area, Israel
    • QC Scientist
      • Jul 2013 - May 2017
      • Jerusalem Area, Israel

  • Ministry of Health Israel
    • Jerusalem Area, Israel
    • Scientist
      • Aug 2012 - Jul 2013
      • Jerusalem Area, Israel

  • Dexcel Pharma
    • Jerusalem Area, Israel
    • QC Analyst Microbiology Laboratory
      • Apr 2010 - Aug 2012
      • Jerusalem Area, Israel

Education

  • 2008 - 2011
    The Hebrew University of Jerusalem
    Master of Science - MS, Life Science & Business administration
  • 2005 - 2008
    Hadassah Academic College
    Bachelor of Science - BS, Biotechnology

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Industry Focus. “Medical Equipment Manufacturing”

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