15 ott - Peschiera del Garda
CEDIC
ppAt Cedic we offer solutions for living. Our diverse product portfolio, specialising in fluid delivery, is designed with the main objective of improving the patient’s quality of life. That is why we continually invest in our people and facilities to remain at the forefront of innovation and responsive to market needs. /ph3Main purpose of the job /h3pThe Quality Specialist performs both Quality System and Quality Assurance activities according to ISO 13485. /ph3Main responsibilities and duties /h3pQuality Assurance: /pulliEnsure the production batches compliance. She/he will be responsible for controlling the batch record documentation and executing the batch release on the ERP according to shipment planning. Supervise the request for additional analysis for sterilization and bioburden control and keep update the record of results /liliManage non-conformity and deviations through the investigation process and documentation analysis, assessing the risk and material disposition in collaboration with DQA and Engineering.
She/he will drive also the root cause investigation involving the necessary functions and departments. Collaborate in management issues linked to sterilization process or to third-party assembly processes. /liliSupport on complaints investigation. /liliMonitor corrective and preventive actions (internal and external) with the managers and provide them with the necessary support to ensure that corrective measures put in place are effective. /liliCommunicate and cooperate with other departments as required to solve issues. /liliManage and ensure the application of procedures in place for contamination control of clean room and facility (clean room validation, monthly analysis of clean room parameters, cleaning plan application, pest control, training staff on entry/exit procedure, etc..). Ensure the execution of the cleaning plan, pest control, and clean room validations. /liliManage the rework activities: track the reworks, participate in the risk analy
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