Supplier Quality Engineer II

Job SummaryProvides technical support to improve the quality, efficiency, output, and safety of existing components and manufacturing processes. Supports critical component and supplier changes, component qualification, inspection methods, tooling, risk analysis, validation, and Quality System activities for aortic stent grafts and delivery systems.Job Details/Responsibilities1) Work with key suppliers to identify and develop component improvements that meet quality, cost, and business requirements and support critical component and supplier changes.Support component qualification activities and improvements and help bring new or existing components through applicable design and qualification phases.2) Develop fixtures, jigs, gages, prototypes, tooling, and equipment that support component inspection, manufacturing, testing, and process improvement activities.3) Document inspection and manufacturing methods and support test-method validation, software validation, and other required validation activities.4) Support the design, evaluation, implementation, monitoring, and operation of systems and processes used to manufacture aortic stent grafts and delivery systems.5) Help develop and implement manufacturing processes and execute process-validation activities, including IQ, OQ, and PQ protocols and reports.6) Conduct risk and statistical analyses, including DFMEA and PFMEA, maintain required documentation, monitor process performance through observations and data, and support CAPAs, NCRs, CQPs, TMVs, and other Quality System activities.Knowledge, Skills and Abilities (KSA)1) Knowledge of engineering statistics and the ability to perform statistical analyses on data groups.2) Knowledge of AutoCAD and SolidWorks.Strong technical-writing skills for manufacturing instructions, test methods, protocols, reports, and related controlled documentation.Ability to organize and conduct experiments independently and analyze and solve technical problems.3) Hands-on ability to engineer and build prototypes, tooling, fixtures, processes, and equipment.4) Knowledge of component qualification, inspection methods, test-method validation, software validation, process validation, and risk-analysis methods, including DFMEA and PFMEA.4) Excellent written and verbal communication skills and the ability to work effectively under pressure.Qualifications/ Background ExperiencesTechnical degree or certificate, or equivalent education and experience.Experience in a technical, engineering, manufacturing, component, tooling, inspection, or validation environment.Medical-device industry experience is preferred.