Flex is seeking an IT Software Validation Engineer in Aguascalientes, Mexico to support medical device manufacturing and quality systems. You will perform CSV activities for software applications and ensure validated environments.
You will create and maintain validation deliverables (URS, FS, IQ/OQ/PQ, validation plans, Traceability Matrices) and ensure compliance with FDA 21 CFR Part 11, ISO 13485, and GAMP 5 throughout the SDLC.