Validation Engineer at Flextronics International USA, Inc in West Columbia, South Carolina

Job Description:

Job Posting Start Date 10-10-2024 Job Posting End Date

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 a Validation Engineer located in Columbia, SC.

Reporting to the Quality Manager, the Validation Engineer independently performs validation activities, as well as manages environmental controls for a Class 8 Cleanroom to ensure that all requirements are effectively met. The Validation Engineer also will support in maintaining quality engineering programs, standards, and improvements within the organization.

What a typical day looks like:

• Develop/maintain User / Functional requirement Specifications (UR/FS).


• Independently produce/execute verification plans, commissioning protocols (FAT/SAT, Hardware & Software Tests).


• Independently produce/execute cleanroom qualification protocols (ISO Class 8).


• Independently produce/execute installation / operation qualification protocols, performance qualification protocols, and associated summary reports.


• Manage and execute change control.


• Support stakeholders during the execution of quality system management, product audits, and inspections.


• Execute assessment of product, reviews of test and other performance data, analysis of market feedback, conducting root cause analysis, quality problem solving, and addressing deficiencies.


• Provide effective oversight of execution of quality, reliability, Risk Management activities, and all activities during the product lifecycle including deliverables created by other functions/organizations to assure product and process compliance.


• Maintains a working knowledge of generic products/services and quality engineering techniques, addresses problems of diverse scope, requiring the evaluation of identifiable factors, demonstrating sound judgment in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.


• Acts as an advisor to cross-functional partners, providing guidance to meet schedules and/or resolve technical problems effectively.


• Cultivates effective relationships, shares knowledge, provides influence over projects and peer groups, demonstrating full understanding of area of specialization, and possesses working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Part 820, ISO 13485, ISO 14644, ISO 14971, and ISO 9001.


• Establishes and improves Quality & Regulatory (Q&R) capabilities supporting customer and leads in deployment of strategy and solutions which exceed customer expectations.


• Independently produces CAPA records and performs timely Corrective and Preventive Action (CAPA) engineering tasks, including assessment of issue descriptions and reviewing CAPA data sources.

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

• Typically requires 5 years of validation engineering experience.


• 4 years of medical device manufacturing experience required (knowledge of medical device regulations).


• Experience with IQ/OQ/PQ is required.


• Experience with CAPAs is required.


• Clean room experience


• Experience with Automated Manufacturing Equipment (prefer)


• Certifications such as ASQ CQE or CQM and ISO 13485 Auditor (prefer)

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

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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