Quality Assurance Analyst Job at FTS, Inc., Kennesaw, GA

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  • FTS, Inc.
  • Kennesaw, GA

Job Description

Our client, a leading company in the medical equipment sector, is seeking a detail-oriented Quality Assurance Analyst to support quality and regulatory compliance efforts across manufacturing and distribution operations.

Key Responsibilities:

  • Perform inspections on incoming materials and finished devices
  • Investigate and manage non-conforming products (MRB administrator)
  • Audit device history records and review final product release files
  • Maintain QA documentation for audits and supplier assessments
  • Oversee environmental monitoring and control in cleanroom areas
  • Support management review reporting and compliance documentation

Qualifications:

  • Bachelor’s degree in Engineering or related field (or equivalent experience)
  • 3+ years in QA within FDA-regulated or medical device environment
  • Familiarity with ISO 13485:2016 and FDA 21 CFR 820 preferred
  • Experience with CAD software (Autodesk or similar) a plus
  • Strong analytical, documentation, and problem-solving skills

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