Quality Assurance Specialist – Medical Devices MI Milano


Reports to the Quality Manager, the Quality Assurance Specialist will be supporting product quality / Quality System activities within different production plants (including plastic moulding, Assembly in Cleanrooms ISO-8) and outsourced activities such as extrusion with different materials including silicone. Works with different functions to effectively monitor processes, identify and correct issues, and continuously improve the area using problem solving tools and metrics. Under the supervision of the Quality Manager, Partners closely with Production team, Manufacturing Engineering, Suppliers and Project Leaders to drive continuous improvement in Quality, Cost, and Delivery on commercial products and to ensure new products are implemented with key process controls and product checks in place using business improvement methodologies such as Kaizen, Lean, Six Sigma models. Key Responsabilities: Works cross-functionally in identifying and resolving technical issues. Contribute to solving technical problems by coordinating and facilitating sessions in collaboration with the various stakeholders; Deploys quality strategies and approaches; key partner in implementing all department and site strategies.Monitor Processes and Metrix including performance indicators to monitors and drives department progress against goals and objectives.Collaborate with the Regulatory team to ensure compliance with company policies & Medical Devices Standards/Laws.Participate to New Product Development Programs Particularly Design Transfers / Change Management activities.Manage Failure Investigations related to potential field performance issues of product.Manages quality discrepancies related to process and product; develops scope, disposition, and corrective actions for prevention of future discrepancies.Monitor 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; Azienda in forte espansioneBuone prospettive di crescitaBachelor’s degree (engineering, a technical field or equivalent) 3+ years of experience in working in Quality Assurance related area.Experience working in a regulated industry (Medical Device, Pharma, Aerospace, etc)knowledge of Quality System principle such as ISO 9001, ISO13485, CFR820.Business improvement methodologies such as Kaizen, Lean, Six Sigma models certification preferredAuditing experience preferredExperience with performing Root Cause Analysis, Change Control and Validations (IQ, OQ,PQ) is preferred.Leadership, initiative and accountability; Impact and influence; RigorousExcellent computer skills including Word, Excel, Power Point and VisioExperience in preparing data and charts for ManagementExcellent organizational skills, analytical abilities, and ability to multi-taskOccasional domestic travel requiredFluent in Italian and English both written and spoken. Biomedical CompanyGreat growth opportunity




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