Senior QE Projects

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My client are a medical device contract manufacturer based in Galway. They provide a broad range of services to design, develop and deliver finished medical devices to market. Due to my client's acquisition by a multi-billion euro technology company, their site in Galway is going from strength to strength and is home to their global HQ. Due to this growth, they need an ambitious Senior Project Quality Engineer to join them. Job Responsibilities:Leads Quality-related projects within the Device Manufacturing Value Stream e.g. where significant process changes are required that originates from a CAPA or a customer complaint.Leads cost improvement projects and NRE activities within the value stream from a quality perspective.Leads quality support for the transfer of new product into device manufacturing.Provides additional support to the operations team when a new product is introduced to the value stream where required until the product has reached steady state.Leads validation activities within the value stream in conjunction with the validation group.Manages the approval of supplier change notifications.Supports audits for the value stream from external regulatory agencies and customers.Updates quality procedures, specs as required through the change plan process.Provides root cause analysis & problem-solving guidance and mentoring. Qualifications/ Requirements:Level 8 degree in Science, Engineering or related subject.5-7 years' relevant supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.Significant project management experience.Experience with New Product Introductions.Knowledge of equipment qualifications, test method validation and process validation. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales