Principal Design Assurance Engineer- Medical DevicePermanentGalwayJob DescriptionOverview: Principal Design Assurance Engineer is the QA technical and compliance expert as part of a cross functional team for the design and development of sterile and non-sterile medical devices and/or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO 13485, CFR820 (QMSR) and governing Regulatory Standards associated with the product classification.ResponsibilitiesRisk AssessmentsDevice testing and associated validationsAudits (internal and external), Support as SME for design processesGeneration and/or approval of technical documents on behalf of the Quality FunctionManage DHFOn-going continuous improvement of the QMSResponsible for compliance of product development and risk management activities with Medical Policies and Procedures and applicable Governing Regulatory RequirementsWork effectively as part of product development team in identifying and translating user requirements and inputs into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc.Complete design verification, design validation and test method validation activities associated with product development activitiesWorks with R&D and Manufacturing Engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of appropriate production process monitoring activitiesLeads the resolution of project issues by working with team members, suppliers, and others as appropriateGenerate and/or Review and approve all operational, test and validation data associated with equipment, materials, components, sub-assemblies and final productProvides technical quality guidance to team members, technicians and inspection staffSystem Administrator for MinitabEnsure compliance to the QMS per QM001 quality manualEssential Skills/ExperienceMinimum Bachelor\'s Degree in Engineering, Science or related technical field6 years QA, Quality System or regulatory experience in the medical industryStrong knowledge of FDA 21 CFR Part 820, ISO 13485:2016, EU MDR and international regulationsExcellent communication, leadership and problem-solving skillsAt Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see wallacemyers.ie/privacy-policy
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