Senior Quality Engineer – Regulatory & Process Excellence

Baxter International Inc.

Tijuana

On-site

MXN 391,000 - 614,000

Full time

9 days ago

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Job summary

Baxter International Inc. in Baja California, Mexico seeks a Senior Engineer, Quality to establish and maintain quality control systems for the designated area, ensuring compliance with QSR 820, ISO-13485, and applicable regulatory standards.

You will lead quality metrics, participate in CAPA/NCR activities, support validation tasks, and supervise Quality Technicians to drive improvements and sustainment projects in a global healthcare setting.

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 statistics.
Knowledge of medical device regulatory requirements (FDA Title 21 CFR Part 820, EU MDR) is desired.

Responsibilities

Establish and maintain quality control systems for the designated area.
Coordinate scheduling and control of quality resources and compliance.
Lead regulatory compliance and quality systems initiatives.
Support validation activities (IQs, OQs, PQs) for designated areas.
Lead or participate in NCR, CAPA and related quality activities.
Analyze data from the field to resolve issues identified through surveillance.
Contribute to project transfers, transfers of processes and quality improvements.