Quality Engineer

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My client are a start-up medical device company based in the heart of Galway. A fast-paced company with a brilliant work culture, this opportunity is not to be missed. My client are currently looking for a Quality Engineer who can come in and establish and maintain an effective quality system structures to ensure consistent implementation of quality systems.Key Responsibilities:Good knowledge and application of quality system regulations and ISO standards.Constantly promotes awareness of best industry practices making appropriate decisions on a daily basis. Champions continuous improvement from a quality system perspective and educates functional areas on quality system requirements.Implementation of internal requirements and external laws, regulations, guidance's and standards, as applicable to the company's quality systems.Participate cross functionally and across the business to standardize and continually improve the Quality System policies and procedures.Lead and support Regulatory Inspections and Notified Body audits.Responsible for compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.Responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organization.Conducting internal audits and maintaining the supplier quality management process.Supporting and providing input into equipment/process validations and test method validations.Supporting operations, clinical and R&D functions from a quality perspective as required.Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.Skills, Qualification & Experience:Degree/ Post-grad in Quality Management (ideally)5+ years experience in a medical device manufacturing environment with experience in Quality Systems and ideally with exposure to ISO13485 If interested, please apply directly and I will contact you with 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