baxter seeks an engineering quality professional in tijuana to manage quality system compliance, including internal audits, document control, and corrective action processes. The role ensures regulatory adherence and supports quality culture initiatives across the manufacturing site.

responsibilities

- ensure compliance with qsr part 820, iso 13485, and applicable regulations
- administer capa and audit systems, including account generation and user training
- coordinate product audits and site regulatory matters
- manage quality documentation control, record storage, and revision distribution
- lead quality culture programs and provide quality systems training to personnel

requirements

- bachelor's degree in engineering
- 1-3 years experience as quality or quality systems engineer
- knowledge of iso 13485 and fda 21 cfr part 820
- proficiency with microsoft office
- familiarity with sap, trackwise, or power bi systems preferred
- understanding of medical device regulatory requirements and standards desirable

📌 Eng quality (Tijuana)
🏢 Baxter
📍 Tijuana