Quality Head - FRESENIUS KABI

Job Title : Quality HeadLocation : Bir Drassen, Beni Khalled, Nabeul TunisiaDescription :Managing the quality department in the production plantImmediate 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 requiredImmediate notification to management on data integrity issues that become knownCoordinating projects related to implementation, improvement and maintenance of qualityDeveloping and implementing the organization's binding quality policy and strategyTechnical/qualitative support of the company's key customers Monitoring quality parameters of manufactured devicesEstablishing, implementing and maintaining processes necessary for the quality management systemPromoting the awareness of QMS, regulations and customer requirements within the organizationProduction controls acc. ISO 9001 / ISO 13485Supervising responsible execution and documentation of in-process and final controls before sterilization acc. test instructionsMonitoring the compliance with the hygiene regulations in the productionInforming the supervisor and production managers when defective products are foundReceiving and inspecting the returned goodsImplement, 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 requirementsEnsure that local operations, including Product / Batch Release, warehousing, storage and distribution are executed in compliance with the global QM Documents and all relevant regulatory requirementsImplement 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 requirementsEnsure an effective and efficient complaint system is available to investigate complaintsMonitor compliance of the local operations with the global QM Documents and all relevant regulatory requirementsMonitor 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 DocumentsEnsure that opportunities for continuous improvement are identified and implemented into the local QMS and local operationsHave managerial oversight on the operations by being present on the Shop FloorsProfile & Requirements :Knowledge in ISO 13485, ISO 14971, MDD, EU-MDR Global MD related QMSMinimum 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 mentalityAble to work in cross functional teamsFluently English (speaking & writing) Ability to lead activitiesEffective problem-solving skillsGood 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