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  • Location

    Rotterdam, Netherlands

  • Job title:

    QA Specialist Medical Devices

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    44048

  • Startdate:

    2020-05-14

QA Specialist Medical Devices

Job Description

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

Responsibilities
  • 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).

Requirements
  • Bachelors degree
  • 3+ years experience in same position
  • ISO 13485 training, Medical Devices ACT and internal auditor experience
  • Fluent in Dutch (a must) and English

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