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Validation Engineer at Flextronics International USA, Inc in Buffalo Grove, Illinois

Posted in Architecture 30+ days ago.

Type: Full-Time





Job Description:

Flex, a Fortune global 500 company, 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 a Sr. Validation Engineer located in Buffalo Grove, IL

Reporting to the Quality Manager, Validation, the Validation Engineer role involves providing validation training and consultation services on validation policies and practices.

What a typical day looks like:


  • Develop and track validation related metrics.

  • Provide validation training and consultation services on validation policies and practices.

  • Work closely with engineering and quality personnel providing expertise and guidance for verifying and validating new products and processes                                                         

  • Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.

  • Provide risk management training and facilitation for FMEA and control plan development sessions.

  • Review, analyze, and provide recommendations for verification and validation test data. (including the ability to interpreted results from Test Method Validation like Gage R&R, process capability, etc.)

  • Provide guidance on resolving deviations and ECO associated with verification and validation activities.

  • Evaluate validation reports to ensure compliance with ISO and FDA regulation requirements.

  • Provide ISO 13485 and FDA regulation guidance (specifically CFR 820).

  • Verify the validation activities as a dedicated subject matter expert to ensure the validation processes fully comply with ISO and FDA regulations requirements.

  • Support process and quality engineering teams for non-conformance analysis and disposition.

  • Interface with customers on technical/quality issues and improvement initiatives.

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


  • Industry experience with medical devices or pharmaceutical

  • 3+ years of experience working as a Validation engineer.

  • Experience with Validation for Automation

  • Bachelors in Mechanical Engineering or Industrial Engineering or related

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


  • Full range of medical benefits, dental, vision

  • Life Insurance

  • Matching 401K

  • PTO

  • Tuition Reimbursement

  • Employee discounts at local retailers

HL45

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Job Category

Design, Process & Technology Engineering

Is Sponsorship Available?

No

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).





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