Senior Quality Engineer, Medical Devices & Compliance

Baxter; Tijuana; On-site; MXN 600,000 - 900,000; Full time

Job summary

Baxter International is seeking a Sr Eng, Quality in Tijuana, Mexico. You will establish and maintain systems for quality control, coordinate scheduling and resources, and ensure regulatory compliance across raw materials, products, packaging, and audits.

You will lead quality initiatives and support sustainment projects under supervision. The role requires troubleshooting, data analysis, and collaboration with cross-functional teams to improve efficiency and ensure product quality and

Qualifications

• B.S. in Engineering or equivalent experience.
• 2–3 years in similar roles.
• Knowledge of ISO13485 quality systems.
• Training in quality control techniques and audits.
• Familiarity with medical device regulatory requirements.

Responsibilities

• Ensure compliance with QSR 820, ISO-13485 and applicable laws.
• Report on quality metrics and supervise performance.
• Lead NCR/SNCR/CAPA activities as needed.
• Develop and update work instructions and validation activities.
• Analyze data from the field to resolve issues from Post Market Surveillance.

Skills

Quality Systems

ISO 13485

CAPA

Gemba Walks

Statistical Tools

Education

B.S. in Engineering

Tools

QMS

Job description

Baxter International is seeking a Sr Eng, Quality in Tijuana, Mexico. You will establish and maintain systems for quality control, coordinate scheduling and resources, and ensure regulatory compliance across raw materials, products, packaging, and audits.

You will lead quality initiatives and support sustainment projects under supervision. The role requires troubleshooting, data analysis, and collaboration with cross-functional teams to improve efficiency and ensure product quality and