Quality Lead

Job SummaryManage the end-to-end CAPA and quality management process, ensuring timely investigation, corrective actions, effectiveness checks, and closure of quality issues. Key ResponsibilitiesManage CAPA, deviations, and nonconformances.Perform root cause analysis and track corrective actions.Monitor CAPA timelines, aging, and effectiveness.Coordinate with cross-functional teams.Maintain quality documentation and metrics.Support audits, inspections, and compliance activities.Required SkillsCAP

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments. Key Resp