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Quality Engineer

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 10th March
Location: Galway
Salary/Rate: £40662 - £49698
Type: Permanent
Start Date: ASAP

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ResponsibilitiesGood knowledge and application of quality system regulations and ISO standards, including ISO13485:2016 & ISO14971:2007 and MDD93/42/EEC, MDR/2017/745, 21CFR820, & 21CFR11.Constantly promote awareness of best industry practices making appropriate decisions on a daily basis. Champion 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. Under the direction Manager, lead and manage the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.Participate cross functionally and across the business to standardise 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 organisation.Conducting internal audits and maintaining/supporting 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.Experience RequiredIdeally will possess Degree/Post-Grad in Quality Management5+ year's experience in a medical device manufacturing environment with experience in a Quality Systems and ideally with exposure to FDA / ISO13485 / CE Registration Process.If you think the position in Galway is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Quality Engineer and looking for more information, I will contact you upon application and discuss this further with you! *Please note sponsorship is not offered with this role.* 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