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The Company: 
The company is located in Hilversum. They are ready to expand their QA team with a highly experienced colleague in QA and Medical Devices.

Role description:
You are responsible for the overall and cross-departmental processes related to Quality. You will improve the QMS in management and design. You will be involved with the multiple tasks on QA base. It can be in process handling till the whole set up for a new market on QA base. You will be part in the begin of the process till they end.  

Responsibilities:

  • Designing, maintaining, safeguarding and optimizing the QMS
  • Responsible for registering, investigating and reporting internal and external complaints, including trend analyzes
  • Responsible for coordinating, conducting and / or supervising internal and external audits
  • Ensures continuous improvement, optimization and compliance of the cross-operating business processes department
  • Initiates improvement proposals and participates in Lean projects
  • Supports the production department and the laboratory in terms of quality
  • The preparation and assessment of validation protocols and reports with regard to software, processes and equipment

Requirements:

  • Bachelor Degree in Scientific field
  • 3+ Yrs Experience in QA Medical Devices
  • Knowledge of: ISO13485 / CAPA / QMS systems
  • Knowledge in the field of automation
  • Dutch is required for this position

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