Estefany Gomez Ramirez

- Transfer existent products to a new production plant, equipment and process definition, purchasing and acquisition, validation and installation on medical production environment.

- Conducted root cause analysis on deviations during validation activities (IQ, OQ, PPQ, SWF), enabling timely resolution of technical issues.

- Composed and executed test protocols and reports for medical devices ensuring engineering requirements were met.

- Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.

- Collaborated during PPQ (Process Performance Qualification) for manufacturing medical process to determinate that is capable of consistently producing finished product using qualified equipment and processes.

- Develop programs for Conformal process, reducing cycle times and improving quality.

- Provided project progress updates and proposed solutions to issues.

-Developed organizational skills through managing multiple tasks simultaneously while adhering to strict deadlines.

- Design spare parts, fixtures and tools. (AutoCAD, SolidWorks).

- Update and standardization of documentation to improve mechanical processes.