Quality Coordinator for medical devices (ISO 13485 and MDR) and VCA

• Demonstrating profound and up to date knowledge of the national and international regulations related to medical devices and Environment, Health & Safety;
• ensuring that the required processes are correctly documented and that the quality of their records is according to standards;
• ensuring the implementation & efficacy of the improvement cycle in the organization (deviations, complaints, internal audits, CAPA);
• assisting departments on selection, qualification and evaluation/validation of suppliers, infrastructure, software, personnel;
• document and evaluate changes (management of change);
• prepare reports on the effectiveness of the quality management system and any need for improvements;
• prepare & support at external audits & (workplace) inspections;
• ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization;
• act as a sparring partner for the different departments in the local organization as well as the QM departments in the B. Braun group;
• collaborate closely with the EHS- responsible (VCA-functionary);
• act diligently and according to corporate complaint guidelines through receiving, documenting & prompt forwarding of complaints/ADRs (Adverse Drug Reaction).

Education/Professional experience

• Master degree or equivalent by experience
• Experience with quality processes and requirements is a major plus

Necessary skills/attitude

• Planning & 0rganisational skills
• Pro-active collaborator with alle departments and stakeholders
• Stress resistant
• Self-starter
• Highly quality focused
• Detail-oriented and strong administrative skills

Knowledge

• Professional IT literacy (MS Office: Word, Powerpoint, Excel, Sharepoint)
• Excellent oral and written Dutch and English skills (French where applicable)