Quality Engineer

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Our client is a growing medical technology business based in London are looking for a Quality Engineer to join their team. The successful Quality Engineer will work with Research & Development (R&D), Product Development, through Operations, Manufacturing, Sales and Marketing etc. Our client is also looking for a candidate who can develop plans of action and communicate them with confidence to 3rd party suppliers and the different functions within the business.They are ideally looking for a candidate that has operated within the Medical Device, Medical Technology or Digital Healthcare/Device industries, in a Quality and Regulatory focused role defining the quality, design documentation and document control in a rapidly growing business.Product and Process ImprovementThe Quality Engineer will work closely with our Customer Care to recover and correctly interpret insights from the field.Help define proposed improvements with Engineering and implement proposed improvements with Manufacturing teams through ECO's.Help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management SystemsRegulation and ComplianceVigilance reportingMaintenance of technical filesRisk based approach to supplier management.Document change control day to day.Day to day administration of the general requirements of the QMS.CAPA, SCAR and NCR investigation and administration.Review of design and development processes.Maintenance of calibration activities and records.Carry out internal and external audits when required.Supplier approval and the associated duties involved in supplier control.RequirementsIdeally a degree in a relevant engineering, design or science discipline (or equivalent qualification/work experience).Appreciation for all stakeholders involved in new product development.Experience in consumer or medical products design and manufacture would be of benefit.A level of experience within a highly regulated industry.Developing Quality Management Systems and the ability to interpret regulations.Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, ISO 13485, 21 CFR 820, and cGMPExperience in CAPA investigation and root cause analysis.Knowledge of Risk Analysis ISO 14971:2012 and IEC60601-1 would be an advantage.Experience auditing to ISO 9001 or ISO 13485 would be an advantage.Able to review and understand hardware, firmware and software requirements and specifications.Must be familiar with commonly used productivity & statistical software such as Microsoft Office 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