Christopher Valdivia Email & Phone Number

Fontana, Ca, Us

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.