Flextronics International USA, Inc

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Quality Engineer (Architecture)



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

The Quality Engineer will be based in West Columbia, SC, reporting to Director of Quality. In this role, you will be maintaining quality/calibration engineering programs, standards and improvements within the organization.

What a typical day looks like:

  • Responsible for internal tracking system for deviations / non-conformances, including issuance, review and approval of corrective and preventive action systems.
  • Responsible for ensuring investigations are robust and that corrections and/or corrective actions taken eliminate the non-conformance.
  • Responsible for the maintenance of the Quality Management System (QMS) and associated documents
  • Lead compliance and process improvement initiatives related to the Quality Management System.
  • Supports QMS Management Reviews, Quality Updates, etc.
  • Assist in the preparation, coordination, and execution of Compliance (ISO) and Regulatory (FDA) audits
  • Establish and maintain successful cross-functional relations with Engineering, Manufacturing, IT, and Quality departments. Coordinate corrective actions for issuance, review, and closure of action plans.
  • Engage with customer, present data / presentations, follow up to ensure resolution on issues
  • Ensure that document release packages are accurate, complete, and current and that all documents are maintained and controlled.
  • Assist in other quality systems responsibilities requested by management to ensure a robust and compliant Quality Management System. 
  • Develop and implement performance metrics.

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

  • 4+ years Quality Engineering experience
  • CAPA (Corrective and Preventive Actions) and NCMR (non-conformance material report) experience
  • Experience with ISO 13485
  • Experience working in a regulated environment
  • Prefer medical device industry experience
  • Validation experience and/or CMM experience is a plus

WHAT YOU'LL RECEIVE FOR THE GREAT WORK YOU PROVIDE

  • Full range of medical benefits, dental, vision

  • Life Insurance

  • Matching 401K

  • Paid Time Off

  • Tuition Reimbursement

  • Employee discounts at local retailers

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Job Category

Quality

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). Apply