Senior Supplier Quality Engineer - Med Devices & Compliance

Baxter International; Tijuana; Hybrid; MXN 420,000 - 640,000; Full time

Job summary

Baxter International is seeking a Supplier Quality Engineer to be a key quality partner with our supplier network, ensuring materials meet regulatory and business requirements.

You will work cross-functionally with Quality, Manufacturing, Engineering, and suppliers to identify risks, resolve complex quality issues, drive supplier performance, and maintain compliance with global quality standards, contributing to product quality and patient safety.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum of 3 years of experience in Quality Engineering, Supplier Quality, Manufacturing Quality, or a related field.
• Experience supporting or conducting supplier quality audits.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 9000 quality management standards.
• Experience managing SCARs, NCRs, corrective actions, and supplier follow-up activities.
• Strong root cause analysis and problem-solving skills using methodologies such as 5 Whys, Fishbone (Ishikawa), or similar tools.

Responsibilities

• Lead supplier quality performance monitoring and drive continuous improvement initiatives that strengthen quality, compliance, and reliability.
• Conduct and support supplier audits while ensuring compliance with FDA regulations, ISO 13485, and ISO 9000 requirements.
• Partner with suppliers to investigate quality issues, identify root causes, and implement sustainable corrective and preventive actions.
• Manage Supplier Corrective Action Requests (SCARs) to ensure timely resolution and measurable improvements in supplier performance.
• Provide engineering support for nonconforming materials and supplier-related quality concerns while minimizing operational impact.
• Analyze supplier quality metrics and communicate trends, risks, and improvement opportunities to business and quality leaders.
• Collaborate with Manufacturing and Quality teams to reduce quality-related inventory issues and improve overall product flow and effectiveness.

Skills

Quality engineering

Supplier quality

Root cause analysis

Bilingual English/Spanish

Education

Bachelor's degree in Engineering

Tools

FDA 21 CFR Part 820

ISO 13485

ISO 9000

Job description

Baxter International is seeking a Supplier Quality Engineer to be a key quality partner with our supplier network, ensuring materials meet regulatory and business requirements.

You will work cross-functionally with Quality, Manufacturing, Engineering, and suppliers to identify risks, resolve complex quality issues, drive supplier performance, and maintain compliance with global quality standards, contributing to product quality and patient safety.