Quality Assurance Director - Breda

Vacancy information

Publication date:November 19 2020
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / QA Manager


For a global leader in the bioprocessing industry, we are looking for Quality Assurance Director. The organisation is a global leader in the field of filtration products and the industries they supply to include medical devices, biotechnology, and pharmaceutical. By supplying these key industries, the organisation has an essential role and aims to improve product quality and safeguard health throughout the entire product lifecycle. Currently, they are scaling up their production activities in the Netherlands by making this their main manufacturing location for the EMEA region. Within the role as a Quality Assurance Director, you will be responsible for the quality department, setting up the quality culture with a newly established team, and be at the forefront of a great adventure full of potential.


Within this role you will have the responsibility of several QC and QA associates/specialist and will be primarily responsible for building the quality culture and maintaining this. The early phase of working activities in this role are building a QA & QC team, building up a Quality Management System and integrating ISO 13485 & GMP, build up a clean room, validate all working processes/machines, and maintain the supplier management program.

Next to those main tasks you carry the responsibility of a big variety of tasks like:

  • Writing/reviewing SOP’s
  • Maintain the quality documentation system
  • Keep employee training up to date
  • Establish the QC microbiology laboratory
  • Design QA and QC reports


We are looking for a candidate with the following profile:

    Mandatory requirements:

    • BSc of science (or a related field)
    • Experience in a people management role
    • 8+ years of experience with ISO 13485 and GMP
    • Experience in a production or manufacturing environment
    • A background in the medical devices, pharmaceutical or biotechnology sector

      Preferred requirements:

      • Experience with LEAN implementation
      • Being a lead auditor


      If you are a result-driven professional and want to make a difference in the world, our client is the perfect fit for you.

      The organisation can offer:

      • Up to €100000 yearly gross salary, depending on your experience
      • Non-contribution pension scheme
      • Social securities
      • Travel reimbursements
      • Holiday allowance of 8%
      • 26 holidays
      • An environment of meaningful innovation and ambitious professionals
      • Opportunity for personal and professional growth


      If you are interested in this job, or in similar ones, please feel free to contact me directly.

      Quintes Hamer
      Associate | Medical Devices

      +31(0)6- 82100758



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