Quality Engineer

2 giorni fa


Mirandola, Italia LivaNova A tempo pieno

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. 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 Responsibilities With respect to Nonconforming product handling, He/She: Collect and critically analyze data and take disposition decision on nonconforming products identified in production Lead 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 CAPA Whenever 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 needed With respect to the Design Control & Production and Process control, He/She: Establishes product quality control plans Reviews process validation planning, protocols and reports Perform preliminary review of the change impact assessment to confirm that quality requirements are met Coordinates investigations of the cause of V&V failures Identify opportunities of quality improvements in the production area and lead improvement plan He/She respects the Health and Safety Regulations in his/her field of competence. Skills and Experience Good knowledge of English (written and spoken) Depth knowledge of Microsoft Office suite Deep knowledge of ISO13485 Good knowledge of Good Manufacturing Practices 1-3 years of experience in medical device or pharmaceutical companies in QA departments. Education Degree in Technical and Scientific disciplines (Physics, Chemistry, Engineering and Biology). Travel Requirements 0 % Welcome to impact. Welcome to innovation. Welcome to your new life. #J-18808-Ljbffr


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