Quality Systems Engineer II

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I am currently helping one of my clients in Galway to recruit for a Quality System Engineer II to join their team on a permanent basis. This is an excellent opportunity for a Quality Engineer with a couple of years of experience to take the next step in their career, and work with a highly innovative company where they will gain exposure to cutting edge technologies and devices. The Company:My client are a Medical Device company who specialise in the development of innovative products designed to address unmet clinical needs. You will be joining their Galway site, where they have recently acquired a start-up specialised in clot management solutions, as part of the expansion of their thrombectomy platform.The Role:The Quality Systems Engineer in this role will be responsible for implementing and maintaining the Quality System, playing a key role in the Quality Team of the Galway site.Responsibilities:Implement and maintain the Quality System in compliance with ISO 13485 /MDD & relevant QSR requirements.Develop the Quality System to meet the needs of the EU Medical Device Regulation 2017/745Lead the implementation of Key quality systems which support the businessNCRCAPADeviationsCoordinate and lead site internal auditing program.Facilitate all Notified Body inspections and auditsFacilitate Senior Management review of the Quality System through metric generation and review.Preparation and maintenance of documentation in compliance with the appropriate regulatory requirementsImplement and manage Change Control processAct as complaint coordinatorRequirements:Level 8 in Science, Engineering or a related discipline.Minimum 3 years experience in a Quality Systems role in the Medical Device industry.If this role looks like something you would be interested in, please apply here for immediate consideration, or contact Tara Toomey at Real Staffing for more information. 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