Overview
Comate develops innovative high‑tech hardware from scratch for pioneering companies, spanning secure cryptowallets, design snowploughs, medical devices, and more. Our products have won international awards and we were voted SME of the year in 2019.
Responsibilities
* Maintain the Comate Quality Management System (QMS) compliant with ISO 13485 by supporting adaptations and improvements.
* Ensure consistent quality within projects (Quality in Projects – QP), supporting teams in correct application of the QMS and development processes, especially for healthcare projects.
* Handle non‑conformities and lead corrective and preventive action (CAPA) processes.
* Manage supplier quality.
* Perform or assist with internal audits and client audits.
* Support production quality control.
Requirements
* Master’s degree in engineering or related field.
* Fluent in English (oral and written).
* Proven commitment to excellence in customer satisfaction, process and product quality, and reliability.
* Attention to detail and high personal quality standards.
* Strong team player with concise communication skills.
* Experience in a quality role or with a quality management system in a medical environment is a plus.
* Thorough understanding of ISO 13485:2016.
* Thorough understanding of ISO 14971:2019 and risk management.
Benefits
* Collaborate with enthusiastic and passionate colleagues.
* Work on the design and development of truly unique products and solutions end‑to‑end.
* Access a broad portfolio of training and educational courses.
* Opportunity to grow within a fast‑growing company.
* Cool office in Leuven or Ghent.
* Attractive salary package with additional benefits.
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