Wendy Jimenez serves as a Principal Sterilization Engineer at Ecolab, where she leverages her extensive expertise in the medical device industry to enhance quality assurance processes within the Quality Department. With a robust background in sterilization and microbiology, Wendy is instrumental in executing and documenting...
Wendy Jimenez serves as a Principal Sterilization Engineer at Ecolab, where she leverages her extensive expertise in the medical device industry to enhance quality assurance processes within the Quality Department. With a robust background in sterilization and microbiology, Wendy is instrumental in executing and documenting sterilization validation protocols, particularly for Ethylene Oxide (EO) and radiation methods. Her role encompasses the meticulous documentation and review of protocols and final reports essential for EO sterilization, ensuring compliance with industry standards such as ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).
In her current position, Wendy coordinates and communicates sample requirements for validation studies, demonstrating her strong analytical skills and attention to detail. She is responsible for documenting quarterly dose audit summaries, which are critical for maintaining the integrity of sterilization processes. Additionally, Wendy reviews routine bioburden and environmental monitoring testing, performing trending analyses that contribute to continuous improvement initiatives within the organization. Her expertise in Good Laboratory Practices (GLP) and her role as a lead auditor further underscore her commitment to maintaining high-quality standards in medical device manufacturing.
Wendy's proficiency in root cause analysis and her experience with standard operating procedures (SOPs) position her as a key player in driving quality system enhancements at Ecolab. Her involvement in the maintenance of sterilization, environmental monitoring, validation, and dose audit programs reflects her dedication to ensuring that medical devices meet stringent safety and efficacy requirements. Through her leadership and technical acumen, Wendy Jimenez continues to make significant contributions to the field of sterilization engineering, fostering a culture of quality and compliance within the medical device sector.
