Quality Engineer
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Our client an international medical devices manufacturer are looking for a Quality Engineer to join the team to allow continuous improvement of the 'cost of quality' objectives across manufacturing 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.Duties:CAPA investigationChange Management Quality lead;Internal Audits - to ISO13485, MDSAP, UK and EU requirements;Product & Process Risk Assessment;Product & Process validation / Approval;Support Technical File required content creation;Lean Manufacturing - e.g. 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;The Quality Engineer will 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;The Quality Engineer will ensure 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.The Quality Engineer will drive improvement to Cost of Quality measures including OEE, Conversion Loss, CAPA and Complaint reduction.Skills / Competencies:Written and verbal communication skills, to support kaizen project implementations;Creative problem-solving and troubleshooting skills, ability to drill down to root-cause using 6? tools;IT Microsoft Office skills, allowing creation of professional SOP / WINs;Internal Audit experience, ideally certified Lead-Auditor qualification (although this is flexible) 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