The Process Quality Engineer supports and facilitates high quality performance, compliance and continuous/process improvement at our Image Guided Therapy Devices (IGTD) Rancho Cordova, CA manufacturing site. Your Role: Analyzes defects for determining dispositions/drives management of Non-Conformances (NC) and Quality Notifications (QN) and implements effective Corrective and Preventive Actions (CAPA) actions. Assists in the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities. Supports operations performance monitoring, risk assessment, reporting, improvement and development, aids with improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and purchasing. Identifies transformative process enhancement opportunities, facilitating the execution of advanced improvement initiatives to optimize operational performance and elevate product quality benchmarks significantly. Applies advanced statistical analysis techniques proficiently to interpret complex data trends and resolve medium to high complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action. Ensures the comprehensive execution of process validation protocols, coordinates multifaceted production activities to bolster process validation efforts and drive continuous process improvements effectively. Prepares and delivers detailed quality metrics and reports to key stakeholders, highlighting significant achievements, emerging trends, and targeted areas for advanced improvement initiatives and regulatory compliance strategies.