Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.
Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Business Systems Analyst located in Tijuana.
Reporting to the IT Software Validation Manager the Business Systems Analyst’s role involves:
What a typical day looks like:
- Analyze current business processes and make recommendations for improvement based on industry trends and professional business knowledge
- Software Validation. 21 CFR Part 11, Electronic Records; Electronic Signatures
- Software Validation following 21 CFR Part 820
- Software Quality reviews and systems audits.
- Software compliance and Gap assessments.
- MES (Manufacturing Execution Systems) Validation (like FlexFlow, MES Pro or equivalent)




- Software Quality Assurance
- Risk Management
- GxP Standards and Compliance (GAMP5)
- Quality Systems Regulations (FDA)
- ISO13485 understanding and compliance for IT
- Failure Modes Analysis (FMEA)
The experience we’re looking to add to our team:
- Intermediate English.
- Software Validation and compliance to 21 CFR Part 11, ERES, Part 820, and GAMP 5.
- Software Quality Engineer working with Validation Engineers to complete the validation documents and review and sign the SIQ, Verification, Validation Protocols and Reports.
- Use SDLC methodology for Risk based approach to software validation.
- Computerized Systems Validations.
- ERP System Validation.
- Working knowledge of GAMP5, 21 CFR Part 11, ERES, 21 CFR part 820, ANSI/AAMI/IEC 62304 Medical Device Software and System Development Life Cycle Process.
What you’ll receive for the great work you provide:
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
EM57
Job Category
IT
**Required Skills**:
Optional Skills:

📌 Business Systems Analyst (Tijuana)
🏢 Flex
📍 Tijuana