Quality Systems Engineer: Impactful Compliance & CAPA

Baxter Healthcare; Tijuana; Presencial; MXN 260.000 - 380.000; Jornada completa

Descripción de la vacante

Baxter Healthcare in Mexico is seeking a Quality Systems Engineer to reinforce our quality operations. You will support CAPA, document and record control, and audit activities, ensuring compliance with ISO 13485 and FDA QSR requirements across the site.

You will coordinate audits, drive quality culture programs, and train personnel on quality systems, while maintaining documentation and change control processes in a fast-paced manufacturing environment.

Formación

• B.S Degree in Engineering is required.
• 1-3 years experience as quality or Quality System engineer.
• Knowledge in ISO 13485 and FDA QSR (21 CFR 820).
• Proficiency with Microsoft Office.
• Knowledge of SAP, Trackwise, Power BI is a plus.

Responsabilidades

• Ensure compliance with QSR part 820, ISO-13485 and applicable laws.
• Manage CAPA system (TW8) administration and user accounts.
• Coordinate product audits and site regulatory matters.
• Lead Quality Culture initiatives and training on quality standards.
• Maintain documentation and change control within Quality Management Framework.

Descripción del empleo

Baxter Healthcare in Mexico is seeking a Quality Systems Engineer to reinforce our quality operations. You will support CAPA, document and record control, and audit activities, ensuring compliance with ISO 13485 and FDA QSR requirements across the site.

You will coordinate audits, drive quality culture programs, and train personnel on quality systems, while maintaining documentation and change control processes in a fast-paced manufacturing environment.