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  • Location

    Amersfoort, Netherlands

  • Job title:

    QA Officer

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QA Officer 

Job Description

As a QA Officer you will be responsible for the overall and cross-departmental processes related to quality assurance and regulatory affairs. You work together with our current QA Officer and report to the QARA Manager.

  • Responsible for designing, maintaining, safeguarding and optimizing the quality system with the help of QMS software
  • Being constantly aware of (local) laws and regulations of countries where we are active (incl. 13485, MDR) and translate this into the quality system
  • Responsible for registering, investigating and reporting internal and external complaints including trend analyzes
  • Responsible for coordinating, conducting and/ or supervising internal and external audits
  • Initiate corrective and preventative measures (CAPAs)

  • Bachelors degree
  • ISO 13485 training, Medical Devices ACT and internal auditor experience
  • Fluent in Dutch (a must) and English