Quality Assurance Engineer

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My client are a medical device start-up based in Dublin 1 who are looking to hire a Quality Assurance Engineer who will support the product development of a structural heart device through design development, verification, clinical trials, validation and regulatory approval.This is a really exciting opportunity to join an exciting early stage company. Responsibilities:Working as a part of a cross-functional team to design and develop a novel transcatheter heart repair device in line with user needsDemonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.Support product verification and validation, including risk management, bio-compatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluationSupport development of test methods for product evaluation and validation, including validations.Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturabilityMitigating risks associated with the design, use and manufacture of Medical devices.Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk managementContinuous improvement of the QMS to meet the requirements of all stakeholdersEnsure product quality requirements are met both internally and throughout the supply chain during product manufacturing.Support quality related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods).Ensuring adherence to all organisational and external regulatory requirements.Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements

Requirements: Degree or masters degree in science or engineering, or related disciplinesMinimum of 3 years of related experience in medical device Quality or Design AssuranceClass III medical product development experience preferredWorking knowledge of FDA, GMP, QSR and ISO 13485 requirements.Previous auditing experience preferred.Experience of statistics and a good working knowledge of test method validation.Experience of preparing technical documentationExcellent communication, organisational and time management skills If this sounds like a good fit for you, please apply directly below and I will reach out to you to provide further details. 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