Quality Compliance Engineer: Product Audit Lead

Baxter International Inc.; Tijuana; On-site; MXN 420,000 - 600,000; Full time

Job summary

Baxter International Inc. in Mexico is seeking a Quality System Engineer to support Quality System compliance by handling internal audits, document and record control, and CAPA activities. You will coordinate product audits and respond to site regulatory matters while ensuring adherence to ISO 13485 and FDA QSR 820 guidelines.

The role requires a B.S. in Engineering and 1–3 years in quality or Quality System engineering, with proficiency in Microsoft Office and familiarity with SAP, TrackWise,

Qualifications

• BS degree in Engineering required.
• 1–3 years of experience as quality or Quality System engineer.
• Knowledge of ISO 13485 and FDA QSRs (Title 21 CFR 820).
• Proficiency in Microsoft Office considered essential.
• Desirable knowledge: SAP, TrackWise, Power BI.
• Regulatory knowledge for medical devices (FDA and MDR).

Responsibilities

• Support Quality System compliance by handling Internal Audit processes.
• Manage Document and Record Control and CAPA system.
• Coordinate product audits and site regulatory matters.
• Administer CAPA and TW8 system; manage user accounts and training.
• Coordinate controlled document releases and quality system records.
• Provide quality system training and ensure GMP practices.

Skills

Quality process experience

Microsoft Office

Education

B.S Degree in Engineering

Tools

SAP

Trackwise

Power BI

Job description

Baxter International Inc. in Mexico is seeking a Quality System Engineer to support Quality System compliance by handling internal audits, document and record control, and CAPA activities. You will coordinate product audits and respond to site regulatory matters while ensuring adherence to ISO 13485 and FDA QSR 820 guidelines.

The role requires a B.S. in Engineering and 1–3 years in quality or Quality System engineering, with proficiency in Microsoft Office and familiarity with SAP, TrackWise,