Quality Head

About the role

We are seeking an experienced Quality Head to lead the quality department of our production plant in Bir Drassen, Beni Khalled, Nabeul, Tunisia. You will be responsible for ensuring product quality, regulatory compliance, and continuous improvement across all manufacturing activities.

Key responsibilities

• Manage the quality department and coordinate projects to implement, improve, and maintain the Quality Management System (QMS).
• Provide immediate notification to management on confirmed quality defects, non‑conformities, complaints, OOX results, data‑integrity issues, and any events requiring competent‑authority reporting.
• Develop and enforce the organization’s binding quality policy and strategy in line with global Fresenius Kabi standards.
• Supervise in‑process and final controls before sterilization, ensuring compliance with ISO 9001, ISO 13485, and hygiene regulations.
• Monitor quality parameters of manufactured devices, oversee product release, warehousing, storage, and distribution.
• Maintain an effective complaint handling system and ensure compliance with GxP and marketing authorisation requirements.
• Track QMS performance using KPIs and facility metrics, driving continuous improvement.

Required profile

• Proven leadership experience in quality management within a regulated manufacturing environment.
• Strong understanding of ISO 9001, ISO 13485, GxP, and global quality standards.
• Ability to communicate QMS requirements and promote regulatory awareness across the organization.
• Hands‑on presence on the shop floor with managerial oversight of operations.

Required skills

• ISO 9001
• ISO 13485
• GxP compliance
• Quality Management System implementation
• Regulatory compliance
• Production control
• Sterilization processes
• Data integrity monitoring
• Complaint handling