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QMS Coordinator

Engineering & Supply Chain

3D Systems Leuven is looking for a QUALITY SYSTEMS COORDINATOR

ABOUT 3D Systems Belgium
3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems.
3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes us a strong innovation partner for customers in the industrial and healthcare sector. We believe in a culture of open communication, supporting each other and the value of trust & respect for the individual.
3D Systems Leuven is part of the 3D Systems group, a world leader in 3D printing.

3D Systems is seeking a highly motivated and detail-oriented engineer to join our team as a Quality Systems Coordinator. In this role, you will play a crucial role in ensuring the quality and compliance of our products by managing and improving our quality management system (QMS). The ideal candidate will have a strong background in quality assurance, regulatory requirements, and a keen eye for process optimization.

• Supervise the development, implementation, and maintenance of the Quality Management System in accordance with applicable standards and regulations.
• Conduct regular reviews and updates to ensure the QMS reflects current industry best practices.
• Manage document control processes for the Belgium facilities in the ETQ system, including document creation, changes, review, approval, distribution and archival.
• Ensure all relevant documentation is kept up-to-date and readily accessible to authorized personnel.
• Develop and deliver comprehensive training programs related to the QMS ensuring all employees are well-informed and compliant.
• Plan, organize and execute regular management review meetings to evaluate the effectiveness of the QMS.
• Collaborate with various departments to address issues, implement corrective actions, and drive continuous improvement based on management review outcomes.
• Establish and manage key performance indicators (KPIs) for CAPAs, complaints and non-conformances.
• Lead, coordinate, prepare audit schedules, and facilitate internal and external audits of the quality management system.
• Collaborate with different departments to address audit findings and implement corrective and preventive actions.
• Author QMS documentation such as CAPAs, complaints and non-conformances, as needed.

• Bachelor’s degree in a relevant field (e.g., engineering, life sciences).
• Minimum of 3 years of experience in quality assurance within regulated industry such as medical devices or aerospace.
• Strong knowledge of relevant quality standards (e.g., ISO 13485, AS9100) and regulatory requirements (e.g., FDA QSR, EU MDR).
• Exceptional attention to detail, demonstrating the ability to identify and address intricate aspects of the quality management system.
• Excellent writing skills to create clear, concise, and accurate documentation for the QMS, reports, communication with regulatory bodies, and authoring of CAPA (Corrective and Preventive Action) documents.
• Excellent attention to detail and organizational skills.
• Effective communication and interpersonal skills.
• Ability to work independently within the context of a collaborative team.
• Proficient in Microsoft Office and document control software.


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