• Facilitates operations performance monitoring, reporting, improvement and development, facilitates improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing.
• Conducts assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Leads analysis of defects for determining dispositions of non-conformances, drives management of Non-Conformances (NC) and Quality Notifications (QN) and facilitates implementation of effective Corrective and Preventive Actions (CAPA) actions.
• Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
• Leads validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.