GXPeople are looking for a QMS Engineer to join a well-established Medical Device manufacturer based in Oxford to join their Quality team.About The RoleThe Quality Management System (QMS) Engineer takes full ownership of the areas of Quality Management System. The role supports the rest of the QA/RA team and wider business with issues related to overall quality assurance, control and compliance.Key ResponsibilitiesSupport quality driven technology driven projects.Development and update of QMS procedures and associated Work Instructions and documentationCompliance to ISO 13485:2016 and/ or Medical Device Single Audit Programme (MDSAP), FDA and other global requirementsUsage of Quality Investigational toolsNot Analysis, Ishikawa, FMEA to identify the true root cause of an event.Manage, Maintain, and Implement CAPAs (Corrective and Preventative Actions)Development of flowcharts to improve QMS process understandingContinuously improving processes to promote more agile workflowsParticipation in the review and approval of processesConduct gap analysis for standards and regulationsProvide QMS Induction training for new startersContribute to product Risk AssessmentPlan and conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal AuditorCo-host Notified Body, regulatory authority and customer audits (with QSM/SRAO)Plan and conduct Design History File and Device Master Record auditsExperience in providing Quality Assurance support for New Product Development, Implementation and LaunchTraining of cross functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP and othersSupport device testing activities (IEC 60601-1, 60601-1-2 etc)Assist in preparation of Technical FilesExperienceExperience and working knowledge of Quality AssuranceExperience in Medical Device ManufacturingUsage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event.Lead Auditor trained and certifiedWorking knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC) and Medical Devices Regulations (EU) MDR 2017/745Unique Device Identification (2013/172/EU)Knowledge of IEC 60601 standards, particularly 60601-1 (Electrical Safety), 60601-1-2 (EMC) and 60601-1-6 (Usability)Experience with Risk Management to ISO 14971If you are looking for a new start in 2025 with a well-established business that have a great reputation in the market please apply to this advert or get in touch for more information.