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Quality Engineer

9 ore fa


Lazio, Italia Livanova Plc A tempo pieno

Position Summary With a high degree of autonomy performs quality work of a broad nature to achieve successful outcomes of departmental and company objectives.The Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality system and the international regulations governing medical device manufacturing and distribution.He/she evaluates situation of non-conforming products, collect and analyse data to propose product disposition and CAPA's to address quality issues.General ResponsibilitiesWith respect to Nonconforming product handling, He/She:Collect and critically analyze data and take disposition decision on nonconforming products identified in productionLead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)Generate the evaluation of the risk posed by the observed NC on products already distributed (HHA) to determine if Stop Shipment and/or FSCA are indicated.Own CAPA process and trend data to identify opportunities for CAPAWhenever applicable support external manufacturers of semi-finished and finished products in the management of any detected non conformities.Notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus the internal production process.He/She gives support to the batch record review for subassemblies/ semifinished products when neededWith respect to the Design Control & Production and Process control, He/She:Establishes product quality control plansReviews process validation planning, protocols and reportsPerform preliminary review of the change impact assessment to confirm that quality requirements are metCoordinates investigations of the cause of V&V failuresIdentify opportunities of quality improvements in the production area and lead improvement planHe/She respects the Health and Safety Regulations in his/her field of competence.Skills and ExperienceGood knowledge of English (written and spoken);Depth knowledge of Microsoft Office suite;Deep knowledge of ISO*****;Good knowledge of Good Manufacturing Practices1-3 years of experience in medical device or pharmaceutical companies in QA departments.EducationDegree in Technical and Scientific disciplines (Physics, Chemistry, Engineering and Biology).Travel Requirements0 %Welcome to impact.Welcome to innovation.Welcome to your new life.#J-*****-Ljbffr