Quality Head - Medical Device Plant

About the role

Fresenius Kabi is looking for a Quality Head to manage the quality department in its production plant in Bir Drassen, Beni Khalled, Tunisia. The role covers quality management, regulatory compliance and production controls, with direct reporting to management on quality defects and data integrity issues.

Key responsibilities

• Develop and implement the organization's binding quality policy and strategy, and coordinate quality improvement projects.
• Establish, implement and maintain a local QMS compliant with the global QM handbook and regulatory requirements, including product/batch release, warehousing, storage and distribution.
• Implement and run an effective complaint system and monitor its effectiveness.
• Monitor quality parameters of manufactured devices and supervise in-process and final controls before sterilization, and hygiene compliance in production.
• Notify management immediately of confirmed quality defects, data integrity issues and required notifications to competent authorities.
• Provide technical support to key customers and promote awareness of QMS, regulations and customer requirements.
• Ensure local operations comply with global QM documents, marketing authorizations, registration dossiers and GxP requirements, and monitor performance against KPIs and facility metrics.
• Lead and manage teams and be present on the shop floors.

Required profile

• Minimum 10 years of QA experience in a regulated industry (medical devices/pharma preferred), including 3 to 4 years as Quality Director.
• Higher professional technical education (e.g. university).
• Experience leading and managing teams.
• Fluent English, speaking and writing.
• Able to communicate at all levels, from senior management to local employees, and to work in cross-functional teams.

Required skills

• Knowledge of ISO 13485, ISO 14971, MDD and EU-MDR QMS.
• Effective problem-solving and leadership skills.