Quality Engineer

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Duties:Overall responsibility for production GMP standards and compliance.Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.Establishing inspection standards, plans, frequencies and test methods.Establishing and maintaining FMEA's.Preparing and updating Operations procedures and associated documentation.Reporting area of responsibility metrics.Supporting customer and surveillance accreditation audits.Perform an active role in quality planning and new product introduction from a quality perspective.Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.Maintain relevant documentation to comply with quality standards and customer requirements.Develop strong links with customer organisation's and other project stakeholders.Quality review of responsible area validation documentation.Performing an active role in further development and continuous improvement of the quality management system.Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.QualificationsLevel 8 degree in Quality / Science / Engineering.Experience within a similar role as Quality Engineer.3+ year's industry experience in a medical device-manufacturing or pharmaceutical environment.Green belt problem-solving qualification preferred.Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.New product introduction and manufacturing process transfer experience would be a distinct advantage.Please Note: Due to the current climate, my client will be conducting all interviews remotely.*This role does not provide sponsorship and all applicants are required to hold Stamp 4 Visa or Full EU Working Rights.* 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