Senior Quality Engineer

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Based in Waterford, this Senior Quality Engineer position is an initial 24 month contract with the possibility of extension.In this medical device company, the Senior Quality Engineer position is vitally important to ensure R&D projects and New Product Set Ups are managed effectively from a Quality perspective. The Senior Quality Engineer will make sure that the Quality management system is adhered to at all times. What does the Senior Quality Engineer do?Work Closely with R&D during the development and introduction of new products and technologies to ensure that all Quality Control Requirements are defined and understood and that they are transferable and maintainable in a production environment.Lead failure analysis PFMEA, to ensure functional specification requirements are fully met during validation.Provide validation support by approval of validation documentation associated with new product validations and technologies.Ensure agreement on acceptance criteria. Work with the Project Team to achieve a robust validated process that is in compliance with regulatory requirements and Global Requirements.Ensure that validation product is properly controlled, segregated and identified.Track, trend and report on Quality performance of new product introductions and technologies post validation.Drive the resolution, analysis and problem solving of new product related issues, working closely with both manufacturing Quality and R&D.Lead CAPA/ Non-conformance activity when required.Ensure the efficient and timely transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment and products. Ensure all appropriate documentation is in place prior to production start. What skills/qualities are required?3rd level Qualification in Science/ EngineeringMinimum 3 years experience in a regulated environment - 2 years in a senior Quality role essential.Full understanding of ISO 13485, 21 CFR Part 820 and Part 11.Experience in providing Quality support for product development/ validation is beneficial Please apply directly below for immediate consideration! 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