Christopher Valdivia Email & Phone Number

West Covina, California, United States

• Investigate and verify customer complaints related to disposable medical products, ensuring a timely completion of evaluations.
• Document and report all observations and tests performed during the investigation of samples and applicable evidence within our Product Lifecycle Management (PLM) system.
• Perform sampling, testing and documentation in accordance to the environmental monitoring program for the detection of ambient microbial contamination of environmentally controlled manufacturing areas.
• Prepare seeded samples to address the biological challenge of the sterilization process utilized in the manufacturing of blood bag products.

Fontana, California, United States

• Verified calibration accuracy of all production-related measuring instruments across two manufacturing sites.
• Documented and maintained tool calibration records in accordance to the quality management system.
• Conducted statistical analysis of scrap data to identify and report the top offending quality issues occurring during production by extrusion and finishing processes.
• Supported and coordinated root cause investigations that resulted in scrap mitigating process improvements for extrusion and finishing processes.
• Issued and tracked CAPA investigations to ensure they reach completion in a timely manner.

Fontana, California, United States

• Developed and finalized 23 standard operating procedures (SOP) pertaining to aluminum extrusion, finishing (paint and anodizing), thermal improvement, shipping, cargo manifesting, and quality control processes
• Managed documentation and work-flow processes to ensure compliance with the quality management system
• Coordinated cross-functional team meetings with the quality department, management, and manufacturing personnel to review operating procedures and develop process improvements
• Facilitated SOP training workshops of 50+ employees, including management, quality, and manufacturing personnel
• Issued and trained preventative measures to manufacturing personnel on recurring quality defects

San Jose, California, United States

• Collaborated with a team of engineers to enhance a process for generating plasma-activated water through an open-air plasma jet system for use in surface sterilization.
• Constructed a statement of work, design of experiment, performed literature & market research, and gage R&R testing that resulted in the fulfillment of project goals.
• Generated and identified trends from data to optimize conditions for improved concentrations of reactive species within the plasma-activated water.