PstrongAbout the Company /strong /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. /ppbr/ppstrongMain purpose of the job /strong /ppThe Quality Specialist performs both strongQuality System /strong and strongQuality Assurance /strong activities according to ISO 13485. /ppbr/ppstrongMain responsibilities and duties /strong /ppemQuality Assurance /em: /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 analysis definition, define actions needed and supervise the effective closures. /liliSupport on New Product Development Programs Particularly Design Transfers / /liliActively managing Change Management activities. /liliReview and approve quality and validation documentation (IQ/OQ/PQ, reports, specifications). /liliSupport auditing activities, internal or versus suppliers. /liliParticipate in quality improvement initiatives and cross-functional projects. /liliManage process non-conformance and supplier corrective action reports (SCAR), when necessary. /liliManage supplier quality activities and qualification processes. /li /ulpbr/ppemQuality Management System: /em /pulliMaintain and improve the QMS in compliance with ISO 13485. /liliEnsure that the processes required for the Quality Management System are established, implemented and maintained up to date. Support in streamline processes and update QMS documentation and procedure accordingly. /liliSupport creation and updates of procedures, forms, and records. /liliCoordinate documentation and change control activities. /liliSupport internal and external audits and follow-up actions. /liliTrack and communicate quality performance indicators. /liliManage Training process /li /ulpbr/ppstrongKey Competencies / Qualifications /Skills /strong /pulliDegree in technical or scientific fields (pharmacy, biology, engineering). /liliPrevious experience of 2-3 years in quality assurance. /liliGood knowledge of the main sterilization technologies with particular reference to sterilization with ETO. /liliGood knowledge of microbiology and related sterility tests, bioburden, etc. /liliStatistical technical knowledge. /liliIn-depth knowledge of standards and standards applicable to the type of activity of the organization (MDD 93/42/EEC, MDR, EN ISO 13485, 21 CFR 820, GMP). /liliExperience in quality systems audit according to EN ISO 13485, 21 CFR 820, GMP. /liliAptitude to contact competent authorities, notified bodies, suppliers and partners of the organization. /liliStrong leadership skills, coordinate and direct working groups, instruct and update staff. /liliAbility to interface with the different departments of the organization. /liliKnowledge of the most popular Computer systems. /liliExcellent written and spoken Italian and English. /li /ul