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Job Summary
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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
- Manufacturing End to End Process interpretation and understanding to apply and run Software Validation task and activities.
- 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)
- 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.
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
Job Category
IT
Required Skills:
Optional Skills:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).