Flex seeks an IT Software Validation Engineer in Aguascalientes, Mexico to support CSV activities for software used in medical device manufacturing and quality systems. You will prepare validation plans and URS/FS, validate systems, ensure FDA 21 CFR Part 11 compliance, and collaborate with IT, Quality, Engineering and Regulatory teams to maintain lifecycle compliance and data integrity.
Experience in regulated environments, ISO 13485, GAMP 5, and SDLC risk management is required; strong English
📌 Medical Device Software Validation Engineer (Aguascalientes)
🏢 Flextronics - The Flex
📍 Aguascalientes
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