Senior Quality Engineer

  • On Site
  • Freelance
  • Medical Devices
  • Senior Quality Engineer

📸 Company in the Spotlight:

For an innovative medical device manufacturer located in the Hoogstraten region, we are currently looking for a Senior Quality Engineer.

The company develops and manufactures specialized medical devices used in cardiac surgery. Their organization combines traditional manufacturing with cleanroom assembly operations and operates within a relatively flat structure where Quality, R&D and production collaborate closely. ​​​​​​

To further strengthen and digitalize their Quality Management System (QMS), the company is looking for an experienced Quality Engineer to support the quality team in managing and improving quality processes across the organization.

Vacancy information

🔮 Your Future Role

As a Senior Quality Engineer, you will play an important role within the quality department.

You will support the implementation and optimization of a digital Quality Management System and ensure that quality documentation and procedures are properly managed and compliant with regulatory standards.

You will contribute to CAPA management, change control, document management and risk management processes while supporting the quality team in maintaining compliance and operational excellence.

You will also support audit preparation and help further structure quality processes within the organization.

✨ Responsibilities

Quality Management System

  • Support the implementation and rollout of a digital QMS
  • Manage and maintain quality documentation
  • Maintain procedures, work instructions and training documentation
  • Support document review and document control activities
  • Quality Processes
  • Support CAPA processes and change management
  • Handle supplier complaints (SCAR)
  • Contribute to risk management activities
  • Support post-market surveillance activities
  • Documentation & Training
  • Implement training modules within the QMS
  • Maintain role descriptions and training documentation
  • Ensure correct documentation management across the organization
  • Audit Support
  • Support internal and external audits
  • Prepare audit documentation
  • Collaborate with the quality team to ensure compliance

Requirements information

  • Master’s degree in engineering, life sciences or related field
  • Minimum 5 years experience in quality within medical devices
  • Strong knowledge of ISO 13485 (mandatory)
  • Knowledge of ISO 14971 (risk management) is a strong plus
  • Experience with QMS systems
  • Experience with CAPA, change management and document control
  • Structured and analytical mindset
  • Strong collaboration skills
  • Languages:
  • Dutch and English

What do we offer

  • Key role within an innovative medical device environment
  • Opportunity to contribute to the digital transformation of the QMS
  • Collaboration with experienced quality and R&D teams
  • Technically challenging environment with real impact on healthcare innovation
  • Full-time position with limited remote flexibility

🚀 Ready to Start?

Novellas Healthcare is an equal opportunity employer. We welcome every talent and do not discriminate based on gender, ethnicity, religion, disability, sexual orientation or any other personal characteristic.

Regular application

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Myriam Van Londersele

Vacancy ID: V-0822

Sr. Staffing Manager

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