Gerardo A. Sanchez Lujan
About Gerardo A. Sanchez Lujan
Gerardo A. Sanchez Lujan is a Quality Assurance/Control Engineer with nine years of experience at Breg, where he focuses on developing processes and layouts for new facilities. He is skilled in process validation and utilizes various statistical tools to analyze production data.
Work at Breg
Gerardo A. Sanchez Lujan has been employed at Breg since 2015, serving as a Quality Assurance/Control Engineer. In this role, he focuses on developing new processes and layouts for facilities, ensuring that production lines are balanced with takt time. His responsibilities include implementing improvements to Quality Systems and Processes, ensuring compliance with FDA-QSR, ISO-13485, and MDSAP standards.
Education and Expertise
Gerardo studied at Universidad Autónoma de Baja California, where he earned a Licenciatura in Ingeniería mecánica from 2009 to 2014. His educational background provides him with a solid foundation in engineering principles, which he applies in his current role. He possesses expertise in process validation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV).
Technical Skills
Gerardo is proficient in various statistical tools, including Run Chart, Pareto, CPk/PPk, Pvalue, Trend Graphics, and Boxplot. These tools aid him in analyzing failures and providing meaningful data for quality assurance. Additionally, he is skilled in using 2D and 3D design programs such as AutoCAD, Solidworks, ANSYS, and Diamino, which are essential for his engineering tasks.
Quality Systems Improvement
Gerardo has developed and implemented improvements to Quality Systems and Processes in alignment with industry standards. His work ensures compliance with regulations such as FDA-QSR, ISO-13485, and MDSAP. He is also experienced in documenting processes for standard work, which contributes to the smooth operation of production lines.
Failure Analysis Expertise
Gerardo has expertise in performing Procedure Failure Mode Effect Analysis (pFMEA). This analytical method allows him to identify potential failures in processes, enabling proactive measures to enhance quality and reliability in production.