Senior Quality Systems Engineer (Medical Devices)

Baxter International Inc.; Tijuana; On-site; MXN 420,000 - 640,000; Full time

Job summary

Baxter International Inc. in Mexico is seeking a Sr Eng, Quality to establish and maintain quality systems across the designated area, ensuring compliance with raw material, product, packaging and regulatory requirements.

You will coordinate the scheduling and control of quality resources and drive continuous improvement under supervision. The role leads quality engineers and technicians, conducts internal audits, supports CAPA activities, analyzes field data, and ensures alignment with critical

Qualifications

• B.S Degree in Engineering or equivalent experience required.
• Two to Three years in similar positions.
• Training - Knowledge of risk management ISO13485.
• Formal education or training in quality control techniques, audits and statistical methods.
• Knowledge of regulatory requirements for medical devices including FDA and EU standards.

Responsibilities

• Establish and maintain quality systems and procedures for the designated area.
• Lead ongoing regulatory compliance and support sustainment projects.
• Coordinate scheduling and control of quality resources and metrics.
• Participate in NCR, CAPA activities and root cause analyses.
• Conduct internal audits and report results to management.
• Analyze data from the field to investigate and resolve issues.
• Support project transfers and ensure quality criteria and deadlines.

Skills

Quality control

Regulatory knowledge

Auditing

Statistical methods

Education

B.S Degree in Engineering

Job description

Baxter International Inc. in Mexico is seeking a Sr Eng, Quality to establish and maintain quality systems across the designated area, ensuring compliance with raw material, product, packaging and regulatory requirements.

You will coordinate the scheduling and control of quality resources and drive continuous improvement under supervision. The role leads quality engineers and technicians, conducts internal audits, supports CAPA activities, analyzes field data, and ensures alignment with critical