Eng Quality (Medical Devices)

Location: Tijuana, Baja California, Mexico; onsite

Company

Developing and manufacturing healthcare products with a mission to save and sustain lives.

What you will do

• Support compliance with the quality system, QSR Part 820, ISO 13485, and other applicable regulations.
• Manage internal audit, CAPA, document control, and record control processes.
• Administer CAPA and audit systems, including account generation, user training, and account release coordination.
• Coordinate product audits and respond to site regulatory requirements.
• Maintain quality documentation, records storage, controlled-copy distribution, and the document matrix.
• Coordinate quality culture initiatives, quality system training, engineering change reviews, and quality KPI reporting.

Requirements

• Bachelor’s degree in Engineering.
• 1–3 years of experience as a Quality Engineer or Quality Systems Engineer.
• Knowledge of ISO 13485 and FDA Quality System Regulations under Title 21 CFR Part 820.
• Knowledge of regulatory requirements for medical devices, including European Medical Device Directive 93/42/EEC and EU MDR.
• Proficiency with Microsoft Office.

Nice to have

• Knowledge of SAP, TrackWise, or Power BI.

Culture & Benefits

• Work in a culture focused on courage, trust, collaboration, ownership, and accountability.
• Participate in quality culture initiatives, including Quality Week, quality communications, quality training, and the Quality Hero program.
• Equal employment opportunity and reasonable accommodation support are provided.