Senior Supplier Quality Engineer - Global Audits

Baxter Healthcare; Tijuana; Presencial; MXN 390.600 - 725.400; Jornada completa

Descripción de la vacante

Baxter Healthcare in Mexico is seeking a Sr Engineer, Supplier Quality to monitor and improve supplier performance across domestic and international audits.

You will plan and execute audits, ensure compliance with FDA CFR 820, ISO 13485, and ISO 9000, and lead corrective actions with suppliers to reduce MRB inventory and improve manufacturing quality.

Degree in Engineering with 3+ years of supplier quality experience and English skills required; ISO 13485 Lead Auditor certification is a plus.

Formación

• Degree in Engineering required.
• Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification.
• English proficiency required.
• Desirable 3+ years of experience.
• Experience with quality auditing, especially supplier audits, preferred.

Responsabilidades

• Plan, coordinate, Schedule, execute supplier audits domestically and internationally.
• Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000.
• Coordinate with sourcing to schedule audits as needed.
• Develop inspection and test techniques to evaluate supplier materials.
• Collaborate with suppliers to resolve identified problems.
• Manage and ensure timely implementation of SCARs.
• Lead supplier approval by assessing manufacturing, quality systems, risks.
• Maintain Incoming Inspection cycle time and address MRB inventory.
• Perform component analysis to determine inspection status changes.

Conocimientos

Audits

Quality Assurance

Supplier Quality

Documentation

Problem Solving

Communication

Educación

Degree in Engineering

Descripción del empleo

Baxter Healthcare in Mexico is seeking a Sr Engineer, Supplier Quality to monitor and improve supplier performance across domestic and international audits.

You will plan and execute audits, ensure compliance with FDA CFR 820, ISO 13485, and ISO 9000, and lead corrective actions with suppliers to reduce MRB inventory and improve manufacturing quality.

Degree in Engineering with 3+ years of supplier quality experience and English skills required; ISO 13485 Lead Auditor certification is a plus.