Quality Head

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