Quality Engineer

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Our client a global medical device manufacturer are looking to add a Quality Engineer to the team.The chosen candidate will drive continuous improvement of the 'cost of quality' objectives across our manufacturing site through systematic, pre-emptive analysis and improvement of process capabilities. This position specifically owns investigations of a critical quality nature, utilising root-cause analysis to identify and implement containment, corrective and preventive actions.Key Duties:CAPA investigation;Change Management Quality lead;Internal 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.Key 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 the QA Manager & Technical Services representative to complete Technical File requirements, from both internal & external sources;Become the 5S Champion for the business, support teams to implement 5S foundations, Train-the-Trainers for each area to ensure 5S is sustained;Identify & 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.Key Skills:Excellent communication skills, to support kaizen project implementations;Creative problem-solving and troubleshooting, ability to drill down to root-cause using 6? tools;High level of IT Microsoft Office skills, allowing creation of professional SOP / WINs;Audit experience would be an advantageCandidates with Quality Engineering from regulated industries are encouraged to apply 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