Quality Engineer

1 month ago

Manchester, United Kingdom Real Staffing Full time

Our client are a fast growing medical technology start-up with a revolutionary non-invasive medical device product looking to revolutionise their respective therapy area.They are looking for a Quality Engineer to be based in their Manchester HQ, reporting to the Quality Manager focused on supplier management and development of the QMS system. The position will also involve Quality Control activities e.g. product inspection and release.Responsibilities:Supplier Management (SCARS, KPl's, Supplier Assessments, Supplier Agreements, supplier re-qualification, supplier monitoring)External audits of suppliersNon-conformances (NCR and CAPA)Customer ComplaintsProduct inspectionsThe Quality Engineer will review, inspect and authorise labelsReview & approve Device History Records (DHR) and other production documentationExecute Product ReleaseRevise existing QMS documentation (SOP's, WI's policies)Contribute to the development of new QMS proceduresContribute to QMS Management ReviewsTrack and trend QMS KPl'sMaintain applicable standardsExperience:Operating to IS013485 and compliant processes & proceduresISO13485 Lead auditor qualified or open to trainingQA and preferably QC experience in a medical device companyDegree qualified or quality qualifications/experienceDesirable:Familiarity with 21 CFR Part 820Supplier evaluation and monitoringProduct inspection and releaseManagement of customer complaints and Non-conformanceLead Auditor qualification 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

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