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The company:
This international Medical Device company is located nearby Gouda. They are active in the Medical Device industry. Since this company is going internationally they expand their department.

Role description:
You will help out the QA/RA Director to set up a plan and create a full focus on QA related questions for this organisation and will responsible about the Audits and Validation. You will be also in charge for internal QMS. 

Responsibilities:

  • Complete quality investigation and product risk assessment for product disposition
  • Facilitate and support in audits
  • Implementation of the Quality Management System– CAPA/Deviations/Internal Audits/Complaints – in line with procedures and regulatory requirements
  • Conduct and implementation of the internal Audit programme
  • In charge over the Internal and external Audits
  • Can work independent when necessary  


Requirements:

  • 5-6 Yrs experience in QA position to work independently 
  • Managing experience in a QA environment 
  • B.S. or B.A. in Engineering, Medical Device or other related discipline
  • Knowledge of applicable foreign and domestic regulations
  • Finished ISO 13485 courses, ISO 14971 is a plus
  • Knowledge of resource planning and project management skills
  • Problem Solving, Analysing and hands on mindset and Attention to detail 

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