Quality Systems Engineer — Audit & CAPA Lead

Zvh; Tijuana; Presencial; MXN 201.000 - 335.000; Jornada completa

Descripción de la vacante

Baxter is seeking a Quality Engineer to support the Quality System by handling internal audits, document and record control, and the CAPA process at our facility in Mexico. The role emphasizes compliance with QSR 820 and ISO 13485, KPI management, and ongoing training in quality systems.

Candidates should have a BS in Engineering with 1–3 years in quality or quality systems, and familiarity with SAP, TrackWise, and Power BI. Strong regulatory knowledge for FDA and EU medical devices is preferred.

Formación

• BS degree in engineering or equivalent required.
• 1–3 years of experience in quality or quality systems.
• Knowledge of ISO 13485 and FDA QSR 820.
• Microsoft Office proficiency.
• Regulatory knowledge for medical devices (FDA 21 CFR 820, EU MDR).

Responsabilidades

• Ensure compliance with QSR 820, ISO 13485 and applicable laws.
• Manage Quality KPIs and prepare corporate-level presentations.
• Administer CAPA system (TW8) and user accounts release.
• Administer TW9 audit system, provide user training, and release accounts.
• Coordinate product audits and respond to regulatory requirements.
• Lead Quality Culture initiatives and training in quality practices.

Conocimientos

Quality engineering

Documentation

CAPA management

Audits

Regulatory knowledge

Educación

B.S Degree in Engineering

Herramientas

SAP

TrackWise

Power BI

Descripción del empleo

Baxter is seeking a Quality Engineer to support the Quality System by handling internal audits, document and record control, and the CAPA process at our facility in Mexico. The role emphasizes compliance with QSR 820 and ISO 13485, KPI management, and ongoing training in quality systems.

Candidates should have a BS in Engineering with 1–3 years in quality or quality systems, and familiarity with SAP, TrackWise, and Power BI. Strong regulatory knowledge for FDA and EU medical devices is preferred.