Senior Quality Engineer

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Job Title: Senior Quality EngineerLocation: Parkmore, Galway.Benefits: Excellent career progression, salary, pension, healthcare and a yearly bonus. Company:My client in the Medical industry are experts in medical device prototyping and 3D printing. They work with companies of all sizes, delivering rapid 3D prototyping services for early stage product design purposes. Responsibilities:Quality support to assigned product development teams ensuring product manufactured conforms to quality standards, specifications, customer expectations, and associated regulations, e.g. FDA, ISO and MDDProvision of functional input into risk management processes such as FMEA development, etcDevelopment of risk-based product/ process validation protocols for existing and new products/ processesAssistance with site to site manufacturing transfersReview and verification of quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areasProvides guidance on equipment calibration procedures as relevantProvides guidance on inspection & test methods and associated sampling plans, etcPerforms analysis of inspection data and associated implementation of ship-to-stock program on relevant incoming componentsNon-conforming product review and disposition, associated investigation and root cause analysis, and implementation of appropriate and effective corrective actionsInitiation, review and approval of document change controlsCAPA ManagementPerformance of internal audits of the QMS. Provide guidance and support on audit outcomes as relevant Qualifications:Bachelor's degree in science-related discipline or equivalent5+ years relevant experience working in medical device-related quality functionQMS Auditor Certification desirable Proficient in:Product and Process Validation, including FMEA, DOE, Test Method Validation, sampling plan analysis, etcRisk Management for Medical Devices and associated toolsSix Sigma Problem-Solving MethodologiesChange ControlNon-Conformance ReportingCAPA ManagementTechnical WritingPresentation SkillsMS Office Applications If you are interested in applying or hearing more about this position forward your CV to the link provided or give me a call to discuss further. 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