Business Systems Analyst
hace 1 mes
Flex Ltd is a diversified manufacturing partner that collaborates with market-leading brands to design, build, and deliver innovative products.
We cultivate a workplace culture of belonging, embracing diversity and inclusion as a competitive edge. Our teams strive to create value and improve people's lives through innovative products.
Job Summary
To support our extraordinary teams, we're looking for a Business Systems Analyst located in Tijuana Campus. Reporting to the Manager IT, this role will focus on exploring complex business problems to develop automated, customized, and standardized systems implementations and solutions.
The ideal candidate will be responsible for designing details for automated systems and processes to enhance efficiency. Additionally, they will work on troubleshooting technical malfunctions, risk research, and stakeholder engagement to deliver viable and consistent solutions.
A typical day involves analyzing complex issues, requiring in-depth evaluation of multiple factors. Key responsibilities include:
Software Validation and compliance to 21 CFR Part 11, ERES, Part 820, and GAMP 5.
Software Quality Engineer working with Validation Engineers to complete validation documents and review protocols and reports.
Use SDLC methodology for risk-based approach to software validation.
Computerized Systems Validations.
ERP System Validation.
Achieving expertise in GAMP5, 21 CFR Part 11, ERES, 21 CFR part 820, ANSI/AAMI/IEC 62304 Medical Device Software and System Development Life Cycle Process.
Required Skills and Qualifications
The successful candidate should have:
BA/BS or equivalent work experience.
Excellent English communication skills.
Sufficient experience in manufacturing processes and IT systems administration roles.
Awareness of operational impact to business processes and other functions.
GxP Standards and Compliance (GAMP5).
Quality Systems Regulations (FDA).
ISO13485 understanding and compliance for IT.
Failure Modes Analysis (FMEA).
Benefits
This position offers a competitive salary: $65,000 - $80,000 per year, depending on experience.
Life and medical insurance.
Christmas Bonus.
Food Coupons.
Saving Fund.
Life Insurance.
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