Medical Device Software Validation Engineer

Flextronics - The Flex Company; Aguascalientes; Presencial; MXN 480.000 - 720.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive Salary

Life & Medical Insurance

Christmas Bonus

Food Coupons

Saving Fund

Descripción de la vacante

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

Formación

• Bachelor's degree in Computer Science, Information Technology, Software Engineering, Biomedical Engineering, or related discipline.
• Minimum 3 years of experience in Computer System Validation (CSV), Software Validation, or IT Validation within Medical Device, Pharmaceutical, or Life Sciences industries.
• Advanced English communication skills, both written and verbal.
• Strong knowledge of FDA regulations, including 21 CFR Part 11, ISO 13485 and GAMP 5.

Responsabilidades

• Develops and executes Computer System Validation (CSV) activities for software applications in medical device manufacturing.
• Creates, reviews, and approves validation documentation including Validation Plans, URS, FS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, and Validation Reports.
• Validates new software systems, upgrades, enhancements, and customized solutions in regulated environments.
• Ensures compliance with FDA 21 CFR Part 11 and applicable quality system requirements.
• Collaborates with IT, Quality, Engineering, Manufacturing, and Regulatory Affairs teams to define validation requirements.

Conocimientos

CSV

Software Validation

FDA regulations

GAMP 5

ISO 13485

SDLC

Risk Management

Change Control

Educación

Bachelor's degree in CS/IT/Software Engineering

Herramientas

ERP

MES

PLM

QMS

LIMS

Descripción del empleo

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