Senior Quality Engineer

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Purpose:Reporting to the RA Manager, the Senior Quality Engineer will be responsible for supporting the quality engineering and regulatory activities which lead to, and maintain, regulatory compliance for the company's products globally.Duties:Responsible for quality engineering for medical devices Responsible for risk management for medical devices Responsible for NC, CAPA and SCAR investigation and timely closure Analyse customer complaints, identify trends and execute corrective actions Maintain risk management files in compliance to EN ISO 14971 Generation and maintenance of Technical Files for medical devices in line with regulatory and site requirements Understand standards and their application to medical devices Apply technical solutions to problem solving Use technical writing skills to clearly describe technical information Planning, protocol generation, and report generation for medical devices Quality Engineering support for R&D projects What You Need Bachelors in Engineering or Science; with 5 years of working within R&D/QA/RA in a medical device environment. 2-3 year's experience in R&D, QA/RA, ValidationsAn advantage to have 2-3 year's experience in Risk, Clinical and Bio-compatibilityExcellent technical writing experience within a medical device environment - essential Please NoteThis process will be conducted completely via VC, with on boarding for the successful candidates conducted remotely.*Sponsorship is unfortunately not provided for this role. All applicants are required to hold Full EU Working Rights or Stamp 4 Visa.* 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