Support the manufacture of medical devices. Work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:Work with Manufacturing Engineers on process improvement and cost reduction projects. Resolve product quality issues and manages non-conformance investigations and corrective actions. Lead/manage QAR/CAPA projects as assigned. Work with Supplier Quality Manager/Engineers to maintain high quality level of incoming production materials. Support process validation by developing or reviewing test protocols and reports. Support equipment qualifications by reviewing equipment specifications, IQ/OQ reports and unscheduled maintenance reports. Support internal and external audits by participating preparation activities and addressing audits findings. Work with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planner to support implementation of new products on Production floor. Work with R&D and Manufacturing Engineers to develop and update pFMEA based on non-conformance reports and complaints. Work with Manufacturing Engineers to perform product quality metric data analysis. Lead projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes. Perform other duties and responsibilities as assigned.