Business Systems Specialist
hace 2 días
At Flex Ltd, we’re looking for a talented Business Systems Specialist to join our team in Tijuana.
The ideal candidate will have strong analytical skills and experience in software validation, compliance, and quality assurance.
The Job Summary is as follows:
Support our teams in building great products by analyzing current business processes and making recommendations for improvement.
Key responsibilities include:
- Software Validation following 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
- 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
Join our team and contribute to our growth by applying today.
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