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