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. /p h3Main purpose of the job /h3 pThe Quality Specialist performs both bQuality System /b and bQuality Assurance /b activities according to ISO 13485. /p h3Main responsibilities and duties /h3 h3Quality Assurance /h3 ul liEnsure 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 /li liManage 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. /li liSupport on complaints investigation. /li liMonitor 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. /li liCommunicate and cooperate with other departments as required to solve issues. /li liManage 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. /li liManage the rework activities: track the reworks, participate in the risk analysis definition, define actions needed and supervise the effective closures. /li liSupport on New Product Development Programs Particularly Design Transfers / /li liActively managing Change Management activities. /li liReview and approve quality and validation documentation (IQ/OQ/PQ, reports, specifications). /li liSupport auditing activities, internal or versus suppliers. /li liParticipate in quality improvement initiatives and cross-functional projects. /li liManage process non-conformance and supplier corrective action reports (SCAR), when necessary. /li liManage supplier quality activities and qualification processes. /li /ul h3Quality Management System /h3 ul liMaintain and improve the QMS in compliance with ISO 13485. /li liEnsure 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. /li liSupport creation and updates of procedures, forms, and records. /li liCoordinate documentation and change control activities. /li liSupport internal and external audits and follow-up actions. /li liTrack and communicate quality performance indicators. /li liManage Training process /li /ul h3Key Competencies / Qualifications / Skills /h3 ul liDegree in technical or scientific fields (pharmacy, biology, engineering). /li liPrevious experience of 2-3 years in quality assurance. /li liGood knowledge of the main sterilization technologies with particular reference to sterilization with ETO. /li liGood knowledge of microbiology and related sterility tests, bioburden, etc. /li liStatistical technical knowledge. /li liIn-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). /li liExperience in quality systems audit according to EN ISO 13485, 21 CFR 820, GMP. /li liAptitude to contact competent authorities, notified bodies, suppliers and partners of the organization. /li liStrong leadership skills, coordinate and direct working groups, instruct and update staff. /li liAbility to interface with the different departments of the organization. /li liKnowledge of the most popular Computer systems. /li liExcellent written and spoken Italian and English. /li /ul /p #J-18808-Ljbffr