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Quality Systems Engineer

Company

Foxconn Baja California, S.A. de C.V.

Location

tijuana, tijuana

Posted

June 11, 2026

Position Overview

            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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Quality Systems Engineer

Position Overview

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