Business Systems Analyst

Tijuana, B.C.
Permanente
Tiempo completo

Hace 17 días

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.Job SummarySummary:To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a “Business System Analyst” will be based in …Tijuana Otay…., reporting to …Principal Assurance Specialist...In this role, you will be In-charge of for exploring complex business problems in order to solve them with automated, customized, developed and standardize systems implementations and solutions, also be in charge of designing details for automated systems and processes in order to make them more efficient. Also designing the framework and process, troubleshooting technical malfunctions, risk research working with stakeholders and delivering a solution that is viable and consistent.What a typical day looks like:

Research complex business problems and propose automated solutions to improve operations and processes efficiency.
In charge of providing technical expertise in identifying, evaluating, and developing systems and procedures that are cost effective, to provide consultation to users related to automated systems
Research, design and test new systems and system enhancements in line with the deliverables of site business/customer's requirements.
Resolve required improvements on the systems & supervise its correct implementation to meet site business/customer’s requirements.
Communicate with users to troubleshoot and resolve day to day system issues to ensure smooth operation.
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)

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

HS115Job Category ITRequired Skills:Optional Skills:Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We 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 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).

Flex

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