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Quality Control Officer

Quality Control Officer

Hytech-PommecRaamsdonksveer, North Brabant, Netherlands
4 dagen geleden
Functieomschrijving

Quality Control Officer    (Medical Devices, ISO 13485) – Raamsdonksveer (32–40 hours)

Are you detail-oriented and passionate about quality in the medical device industry? Do you enjoy working with documentation, compliance, and supporting quality processes in a hands-on environment? We’re looking for a proactive  Quality Control Officer  to join our team in Raamsdonksveer and support our recently appointed QA Manager in strengthening our quality systems.

About the Role

As  Quality Control Officer  , you will play a vital role in supporting the implementation and maintenance of our QMS according to ISO 13485 and MDR. Your main responsibilities will be executing quality procedures, monitoring outcomes, verification of compliance and ensuring proper documentation of QMS records. In addition, you will be responsible for document control, assist with audits, NCRs, CAPAs, Feedback, Complaint handling and ensure quality records are well maintained and up to date. You will work closely with the QA Manager and collaborate with cross-functional teams across the organization.

This is an ideal opportunity for a candidate with a background in QC in medical devices, who enjoys structure, precision, and working in a dynamic and growing production environment.

Key Responsibilities

  • Support the QA Manager in daily quality-related tasks
  • Create and maintain controlled documents and records in accordance with ISO 13485 and MDR
  • Perform and support product inspections and sampling activities
  • Assist in the preparation and execution of internal and external audits
  • Support handling of non-conformities (NCRs) and implementation of CAPAs
  • Assist in training coordination and ensure procedures are followed correctly
  • Contribute to the continuous improvement of QA processes and outputs
  • Help ensure compliance with MDR Annex IX and relevant regulatory requirements

What We’re Looking For

  • Minimum 2 years of experience in a Quality Control role within the medical device industry
  • Strong understanding of ISO 13485 (mandatory)
  • A proactive mindset with the persistence to follow through on tasks and ensure completion
  • Strong interpersonal skills; able to work effectively with colleagues across various departments
  • Comfortable taking initiative and independently identifying areas for improvement
  • Positive attitude and team player, with the ability to motivate others to follow quality procedures
  • Experience with document control and QMS systems
  • Familiarity with MDR and ideally Annex IX
  • Strong attention to detail and organizational skills
  • Proactive, hands-on attitude
  • Fluency in English (Dutch is a plus, but not required)
  • Available for 32 to 40 hours per week
  • Based in or near Raamsdonksveer, or willing to commute

    • About Us

    We are a fast-growing company and a global leader in the field of hyperbaric technology. Our main markets are commercial diving, tunneling, government, and medical. We are located in Raamsdonksveer, and our team consists of approximately 75 dedicated professionals. Our hyperbaric oxygen therapy chambers are medical Class IIb devices. We are the only manufacturer of this product type in the Netherlands, with full in-house production and servicing. Our products are shipped worldwide, and our growing international presence makes quality and compliance our top priority.

    What We Offer

  • A flexible position (32–40 hours per week)
  • A key support role in a growing company with room to develop
  • Competitive salary based on your experience
  • 40 vacation days (based on a full-time contract)
  • Flexible working hours and a great team atmosphere

    • If you are an intermediary, please do not contact us!

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    Quality Officer • Raamsdonksveer, North Brabant, Netherlands