Job Description

Responsibilities
  • Provide quality support to production lines and catheter assembly processes
  • Ensure compliance with GMP, GDP, and ISO 13485 requirements
  • Investigate NCRs, process deviations, and manufacturing failures
  • Lead root cause analysis activities using 8D, 5 Why’s, Fishbone, and CAPA methodologies
  • Monitor quality KPIs, scrap trends, and rework performance
  • Support process validations, engineering changes, and continuous improvement initiatives
  • Participate in internal, corporate, and regulatory audits
  • Collaborate with Manufacturing, Process Engineering, Validation, and Quality teams
Qualifications
  • Bachelor’s degree in Engineering or related field
  • 2–3 years of experience as a Quality Engineer within the medical device industry
  • Experience in catheter manufacturing or medical device assembly operations
  • Knowledge of ISO 13485, FDA 21 CFR Pa...

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