Van Cao

About Van Cao

My expertise lies in implementing and overseeing robust quality management systems, driving process improvements, and ensuring regulatory compliance. I am passionate about optimizing operations to enhance efficiency, reduce costs, and deliver exceptional results.With a deep understanding of regulatory compliance and industry best practices, I have successfully led cross-functional teams, implemented quality management systems, and streamlined operations to ensure compliance with FDA and ISO regulations. My expertise extends to risk management, CAPA implementation, supplier quality management, and internal/external audits.

Experience

1. Quality Manager

   Penumbra, Inc.

   Nov 2023 — Present

   Successfully led and optimized a team of quality professionals, resulting in improved inspection cycle times and fewer non-conformances.• Enhanced inspection processes through the use of statistical analysis tools and developed improved training protocols for staff.• Contributed to the successful completion of ISO audits with no findings, reflecting strong compliance management and operational excellence.• Oversaw and managed the full range of inspection activities, including incoming, in-process, packaging, labeling, and engineering development inspections, ensuring compliance with FDA Quality System Regulations (QSR), ISO standards, and Medical Device Directive (MDD).• Directed and motivated a team of Quality Supervisors, Inspectors, and Specialists, fostering a high-performance culture and ensuring timely and accurate inspection operations.• Developed and implemented inspection schedules and shift plans to meet production goals, effectively managing labor and material resources.• Monitored and ensured adherence to company quality management systems (QMS), FDA regulations, and global standards for medical device manufacturing, ensuring full regulatory compliance.• Led non-conformance investigations, identifying root causes and implementing corrective and preventive actions (CAPAs) to mitigate issues in manufacturing and inspection processes.• Maintained inspection records and continuously reviewed and approved change orders and documents related to quality management, ensuring compliance with both internal and external quality systems.• Utilized analytical tools such as Statistical Process Control (SPC), Process Capability, Gage R&R, and risk analysis to continuously improve the quality control process and maintain product integrity.• Generated and analyzed quality metrics to identify trends and areas for improvement in inspection department operations.

Education

• DeVry University

  Bachelor's degree, Technical Management

• San José State University

  Civil Engineering