Quality Assurance Engineer – Medical Device Complaints

Cardinal Health; Baja California; On-site; MXN 600,000 - 1,000,000; Full time

Job summary

Cardinal Health is seeking a Quality Engineer to manage the full customer complaint lifecycle in a regulated medical device environment. You will coordinate investigations with cross-functional teams and maintain quality databases and KPIs to ensure timely, accurate reporting.

Role requires strong English communication, ISO 13485 knowledge, and experience with complaint handling. The position supports audits and process improvements while aligning with corporate quality standards.

Qualifications

• Bachelor's degree in Engineering, Quality, Science, or related field.
• Strong knowledge of ISO 13485 and regulatory requirements.
• Experience with complaint handling and investigations is preferred.

Responsibilities

• Administers the complete customer complaint process following procedures and regulatory requirements.
• Coordinates complaint investigations with technicians and cross-functional teams.
• Maintains complaint databases, dashboards and KPIs with data accuracy.
• Supports audits by FDA, regulatory bodies, and internal teams.
• Performs root cause analysis and documents investigation outcomes.
• Ensures sample handling and chain of custody for investigations.

Skills

Root cause analysis

Quality documentation

Cross-functional collaboration

ISO 13485 knowledge

Regulatory compliance

Education

Bachelor's degree in Engineering/Quality/Science

Tools

TrackWise

Salesforce

SAP or equivalent

Job description

Cardinal Health is seeking a Quality Engineer to manage the full customer complaint lifecycle in a regulated medical device environment. You will coordinate investigations with cross-functional teams and maintain quality databases and KPIs to ensure timely, accurate reporting.

Role requires strong English communication, ISO 13485 knowledge, and experience with complaint handling. The position supports audits and process improvements while aligning with corporate quality standards.