# Quality Head

- **Entreprise** : [FRESENIUS KABI](https://www.keejob.com/offres-emploi/entreprises/34077/fresenius-kabi-bir-drassen/)
- **Lieu** : Beni Khalled, Nabeul, Tunisie
- **Type de contrat** : CDI
- **Niveau d'études** : Bac + 5
- **Expérience** : Plus que 10 ans
- **Langues** : Français, Anglais
- **Métiers** : Directeur Qualité
- **Date de publication** : 2026-09-26
- **Date d'expiration** : 2026-09-26
- **Référence Keejob** : 245524
- **Statut** : Offre expirée

## Description

**

**Job Title :  Quality Head**

Location : Bir Drassen, Beni Khalled, Nabeul Tunisia

  

**

**Description :**

  * Managing the quality department in the production plant
  * Immediate notification to management on confirmed, reportable quality defects that become known from nonconformities, complaints, OOX results or other events and when notification to concerned Competent Authorities is required
  * Immediate notification to management on data integrity issues that become known
  * Coordinating projects related to implementation, improvement and maintenance of quality
  * Developing and implementing the organization's binding quality policy and strategy
  * Technical/qualitative support of the company's key customers Monitoring quality parameters of manufactured devices
  * Establishing, implementing and maintaining processes necessary for the quality management system
  * Promoting the awareness of QMS, regulations and customer requirements within the organization
  * Production controls acc. ISO 9001 / ISO 13485
  * Supervising responsible execution and documentation of in-process and final controls before sterilization acc. test instructions
  * Monitoring the compliance with the hygiene regulations in the production
  * Informing the supervisor and production managers when defective products are found
  * Receiving and inspecting the returned goods
  * Implement, operate and maintain a local QMS in compliance with gQMH-001 "Global Quality Management Handbook" of Fresenius Kabi and the global QM Documents and all relevant regulatory requirements
  * Ensure that local operations, including Product / Batch Release, warehousing, storage and distribution are executed in compliance with the global QM Documents and all relevant regulatory requirements
  * Implement local QM Documents to ensure that all products / batches are manufactured, tested and released In compliance with the respective Marketing Authorizations, registration dossiers and all other relevant regulatory requirements incl. GxP requirements
  * Ensure an effective and efficient complaint system is available to investigate complaints
  * Monitor compliance of the local operations with the global QM Documents and all relevant regulatory requirements
  * Monitor effectiveness and performance of the local QMS and the local operations according to Key Performance Indicators and facility Metrics Meetings as required by the relevant global QM Documents
  * Ensure that opportunities for continuous improvement are identified and implemented into the local QMS and local operations
  * Have managerial oversight on the operations by being present on the Shop Floors

**Profile & Requirements :**

  * Knowledge in ISO 13485, ISO 14971, MDD, EU-MDR Global MD related QMS
  * Minimum 10 years ( 3 to 4  years as Quality director ) of QA experience in a regulated industry (Medical Devices/Pharma preferred)
  * Professional, responsible, reliable, enthusiastic, proactive person with a hands-on mentality
  * Able to work in cross functional teams
  * Fluently English (speaking & writing) Ability to lead activities
  * Effective problem-solving skills
  * Good communicator; capable to communicate at different levels (with senior management, RA experts, local employees, other PU's)
  * Higher professional technical education (e.g. University)
  * Experience in leading and managing teams

## Postuler

Cette offre n'est plus active. Page de l'offre : https://www.keejob.com/offres-emploi/245524/quality-head/

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Source : Keejob.com, le site de l'emploi en Tunisie.