Role DescriptionThis role serves as Quality Engineering representative for medical device products and associated manufacturing processes. This position is responsible for collaborating with internal departments and external contract manufacturing organizations (CMOs) to ensure compliance. Additionally, this position shall lead and support Quality related activities and ensure effective implementation of improvements on identified projects/systems. Provide similar support for quality events, CAPAs, and audit records in eQMS. Provides audit and inspection support.Job RequirementsSkills: Excellent communication, presentation, time management, cross-functional collaboration skills; attention to detail, multi-tasking, experience in medical devices, and strong computer skills (Word, Excel, PowerPoint, Minitab).Experience in:Quality with respect to manufacturing and designValidationDesign ControlData Analysis and Statistical TechniquesInvestigations and Root Cause AnalysisCAPA and NCLean Six Sigma toolsExperience: 5+ years in a similar role is strongly preferred, in cGMP, medical device, or regulated industry (including QA or engineering experience).Education: BS in Science, Engineering, or equivalent combination of Education, Experience and Competencies.Preferred Six Sigma Certification or ASQ Certified Quality EngineerJob ResponsibilitiesProvide Quality support for design control and development activities for new products and design changes.Collaborate with Quality, R&D, and CMOs to use appropriate Six Sigma techniques during development and design changes (statistical sample plans, Gage R&R, DOE, process capability, reliability analysis, tolerance stack up, etc).Author and assist in providing design control deliverables to ensure development phase requirements are documented and compliant.Lead risk management activities for new product design and current product design changes.Collaborate in development of verification and validation plans and reports.Lead root cause analysis investigations on medical device products in conjunction with CMOs. Work with CMOs to identify and implement appropriate corrective actions to eliminate current problems and prevent future problems.Serve as Quality Representative for change control, quality events, CAPAs, and audit records in eQMS. Work with external CMOs to resolve technical issues as needed.Provide Supplier Quality functions. Qualify new suppliers, maintain Approved Supplier List (ASL), establish and maintain supplier audit schedule, and perform audits.Coordinate and facilitate Quality System Management Reviews.Serve as SME for internal audits and regulatory inspections.Job BenefitsCompetitive salary and benefits package.Opportunities for professional development and career growth.Collaborative and innovative work environment.Work Details:Site/ Primary Work Location:Dublin D15, IrelandPrimary Work Model:HybridDepartment:QualityReporting to (Title):Director, Supplier QualityHours:Full-timeTravel Expectations:Up to 25%, as needed for CMO, Design, and audit/ inspection supportPhysical Requirements:NoneDisclaimer:The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.