Delivery Business Systems Analyst ( Regulations FDA)

at  Flex Ltd

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.
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 Summary
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add an Business systems Analyst, located in, Tijuana Campus.
Reporting to the Manager IT the Business Systems Analyst
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:

• Work on complex issues where analysis of situations or data requires in-depth evaluation of multiple factors.
• 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

The experience we’re looking to add to our team:

• BA/BS or equivalent work experience.
• English
• Sufficient experience in manufacturing processes and IT systems administration roles.
• Has awareness of the operational impact to business processes and other f
• GxP Standards and Compliance (GAMP5)
• Quality Systems Regulations (FDA)
• ISO13485 understanding and compliance for IT
• Failure Modes Analysis (FMEA)

What you’ll receive for the great work you provide:

• Competitive Salary
• Life & Medical insurance
• Christmas Bonus
• Food Coupons
• Saving Fund.
• Life Insurance

GR66
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)

Please refer the Job description for details