Quality Systems Engineer – Product Audit Lead

Baxter International Inc.; Tijuana; On-site; MXN 360,000 - 600,000; Full time

Job summary

Baxter International Inc. in Mexico is seeking a Quality/Engineering professional to support Quality System compliance through internal audits, document control, and CAPA management.

Responsibilities include ensuring compliance with QSR 820 and ISO 13485, managing CAPA system TW8, administering TW9 audits, and coordinating product audits. A B.S. in Engineering and 1–3 years in quality are required, with SAP/Trackwise/Power BI as assets.

Qualifications

• B.S Degree in Engineering required.
• 1-3 years of experience as quality or Quality System engineer.
• Knowledge in ISO 13485 and FDA 21 CFR Part 820.
• Use of Microsoft Office.
• Knowledge desirable on systems such as SAP, Trackwise, Power BI.
• Regulatory knowledge including FDA and European directives is a plus.

Responsibilities

• Ensure compliance with QSR part 820, ISO-13485 and other applicable laws.
• Ensure Quality KPIs at plant level and prepare presentations at corporate level.
• Manage CAPA system (TW8) including education on operation and user account releases.
• Administer Audit system (TW9) including user accounts and release of accounts.
• Coordinate product audits and respond to site regulatory requirements.
• Support Quality Culture programs and training in quality practices.

Skills

Quality management

Auditing

CAPA administration

MS Office

Education

B.S Degree in Engineering

Tools

SAP

Trackwise

Power BI

Job description

Baxter International Inc. in Mexico is seeking a Quality/Engineering professional to support Quality System compliance through internal audits, document control, and CAPA management.

Responsibilities include ensuring compliance with QSR 820 and ISO 13485, managing CAPA system TW8, administering TW9 audits, and coordinating product audits. A B.S. in Engineering and 1–3 years in quality are required, with SAP/Trackwise/Power BI as assets.