Quality Assurance Engineer - Medical Devices

Cardinal Health, Inc.; Tijuana; On-site; MXN 420,000 - 640,000; Full time

Job summary

Cardinal Health, Inc. in Mexico is seeking a Quality Engineer/Senior Complaint Handling professional to administer the full customer complaint process, coordinate investigations, and maintain quality databases.

You will work with cross-functional teams, support audits, perform trend analyses, and ensure compliance with ISO 13485 and FDA QSR. Fluency in English and 3+ years in regulated industries are preferred.

Qualifications

• Bachelor's degree in Engineering, Quality, Science, or related technical field.
• Advanced English proficiency with strong technical writing for reports.
• Minimum 3 years in medical device or regulated industry with complaint handling.
• Knowledge of ISO 13485, FDA QSR, MDSAP, and complaint-handling requirements.
• Experience with root cause analysis and problem-solving tools.

Responsibilities

• Adminsisters the complete customer complaint process from intake to closure.
• Coordinates investigation activities with technicians and cross-functional teams.
• Reviews no-sample/no-lot complaints per procedures.
• Maintains complaint databases, dashboards, and KPI reporting.
• Supports regulatory audits (FDA, regulatory bodies, audits).
• Verifies information and ensures objective evidence is documented.
• Manages import, tracking, and chain of custody for complaint samples.
• Performs trend analysis and communicates status and progress to stakeholders.

Skills

Root cause analysis

Data analysis

Cross-functional communication

Technical writing

Investigation

Complaint handling

Education

Bachelor's degree in Engineering/Quality/Science or related field

Tools

TrackWise

Salesforce

SAP

Job description

Cardinal Health, Inc. in Mexico is seeking a Quality Engineer/Senior Complaint Handling professional to administer the full customer complaint process, coordinate investigations, and maintain quality databases.

You will work with cross-functional teams, support audits, perform trend analyses, and ensure compliance with ISO 13485 and FDA QSR. Fluency in English and 3+ years in regulated industries are preferred.