Quality Engineer

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Quality Engineer (Medical Devices) Our client a medical device manufacturer operating internationally based in South Devon are looking for a Quality Engineer to join an expanding team. The chosen Quality Engineer will drive continuous improvement of the 'cost of quality' objectives across manufacturing through systematic, pre-emptive analysis and improvement of process capabilities. This position owns investigations of a critical quality nature, utilising root-cause analysis to identify and implement containment, corrective and preventive actions. Duties:CAPA investigation;Change ManagementInternal AuditsProduct & Process Risk Assessment;Product & Process validation / Approval;Support Technical File required content creation;Lean Manufacturing - 5S, OEE, Conversion Loss, Right First TimeOwn and maintain procedures, forms and records covering responsibilities of this position.Responsibilities: CAPA management, Root Cause Analysis, Risk assessment & Action/s effectiveness reviews;Implement of kaizen projects based on complaints Target & Trend analysis, post-market surveillance or direct departmental feedback;FMEA, Control Plan, CAPA reviews to ensure Risk Priority Numbers remain current & valid. Process controls implemented as a result need to loop back into the high-level Risk Management database;Completion of Product & Process validations, ensuring all documentation is retained and/or linked to the relevant Technical Files;Work with Management & Technical Services representative to complete Technical File requirements, from both internal & external sources;Support teams to implement 5S foundationsIdentify & implement visual management throughout the business, create a standardized approach.Drive improvement to Cost of Quality measures including OEE, Conversion Loss, CAPA and Complaint reduction. Skills: Written and verbal communication skillsProblem-solving and troubleshooting skills, ability to drill down to root-causeHigh level of IT Microsoft Office skillsIdeally audit experienceTrack record in a regulated sector e.g. medical devices, pharmaceutical, automotive, aerospace, defence etc.Quality Engineering 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