Senior Supplier Quality Engineer: Global Audits & Compliance

Baxter International Inc.; Tijuana; Presencial; MXN 90.000 - 130.000; Jornada completa

Descripción de la vacante

Baxter is hiring a Senior Engineer in Supplier Quality in Tijuana to join a global team focused on monitoring and improving supplier performance. You will plan, coordinate, and execute supplier audits, ensure compliance with FDA CFR 820, ISO 13485, and ISO 9000, and drive corrective actions with suppliers.

The role emphasizes collaboration with sourcing, manufacturing, and quality engineers to reduce MRB and improve inspection processes.

Formación

• Degree in Engineering required.
• Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification
• English
• Desirable experience: 3 years or more of experience.
• previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving skills are desirable.

Responsabilidades

• Plan, coordinate, Schedule, execute supplier audits domestically and internationally as required.
• Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000.
• Work with sourcing staff to coordinate supplier audits activities as required.
• Develops inspection and test techniques to evaluate supplier materials.
• Works with suppliers to find solutions to identified problems.
• Manage and insure timely implementation of supplier Corrective Action Reports (SCARs).
• Lead the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks.
• Manages personnel maintain and reduce the Incoming Inspection cycle time.
• Establishes problem solving strategies and work with Manufacturing and Quality Engineers to reduce MRB inventory.
• Perform component characteristic analysis to determine inspection status changes.

Conocimientos

Supplier quality

Audits

Documentation

Problem solving

English

Educación

Engineering degree

Descripción del empleo

Baxter is hiring a Senior Engineer in Supplier Quality in Tijuana to join a global team focused on monitoring and improving supplier performance. You will plan, coordinate, and execute supplier audits, ensure compliance with FDA CFR 820, ISO 13485, and ISO 9000, and drive corrective actions with suppliers.

The role emphasizes collaboration with sourcing, manufacturing, and quality engineers to reduce MRB and improve inspection processes.