Senior Engineer, Quality (Medical Devices)

Location: Tijuana, Baja California, Mexico

Company

Healthcare company focused on developing and delivering solutions that support its mission to save and sustain lives.

What you will do

• Establish and maintain quality control systems, procedures, plans, inspection specifications, and critical performance metrics.
• Ensure compliance with QSR 21 CFR Part 820, ISO 13485, and other applicable regulatory requirements.
• Manage non-conforming material processes and support NCR, SNCR, CAPA, validation, and root-cause analysis activities.
• Analyze field data, investigate post-market surveillance issues, and support field actions and customer information requests.
• Support project transfers, manufacturing-process improvements, product acceptance criteria, value-stream initiatives, and quality-related cost and efficiency improvements.
• Coordinate and supervise Quality Technicians and Quality Interns, while conducting internal audits, Gemba activities, and LTTs.

Requirements

• Bachelor’s degree in Engineering or equivalent experience.
• Two to three years of experience in similar quality engineering positions.
• Knowledge of risk management under ISO 13485.
• Training in quality control techniques, quality system audits, statistical tools, design of experiments, statistical sampling, testing methods, and Lean principles.
• Experience or knowledge related to medical-device regulatory requirements and quality systems.

Nice to have

• Knowledge of FDA medical-device requirements under Title 21 CFR Part 820.
• Knowledge of European Medical Device Directive 93/42/EEC and EU MDR.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Culture emphasizing courage, trust, collaboration, ownership, and accountability.
• Equal employment opportunity and reasonable accommodation support for candidates with disabilities.