senior quality engineer position in tijuana responsible for establishing and maintaining quality control systems, ensuring regulatory compliance, and managing quality resources across manufacturing operations. Reports to supervisor and leads quality technicians and interns.

responsibilities

- establish and maintain quality control standards and procedures for designated manufacturing areas
- coordinate quality resource scheduling and ensure compliance with regulatory specifications
- lead regulatory compliance activities and quality system management
- supervise and coordinate quality technicians and quality interns
- conduct root cause analysis, investigations, and corrective action activities (ncr, capa)

requirements

- bachelor's degree in engineering or equivalent experience
- two to three years in similar quality engineering roles
- knowledge of iso 13485 risk management
- training in quality control techniques, auditing, and statistical tools
- familiarity with lean principles and design of experiments
- desired: knowledge of fda title 21 cfr part 820 and european medical device regulations

📌 Sr eng, quality (Tijuana)
🏢 Baxter
📍 Tijuana