We are seeking an experienced training leader with a strong background in Class III medical device manufacturing, preferably catheter production within an ISO Class 8 cleanroom environment.

This position will lead the site’s training and competency management strategy, ensuring workforce qualification, regulatory compliance and operational readiness within a highly regulated manufacturing environment.

Key Responsibilities:
Lead the training and competency management system for direct and indirect personnel.
Own the Training System, ensuring alignment with quality, regulatory, and business requirements.
Manage training matrices, competency assessments, training records, and qualification status.
Develop training strategies focused on technical, quality, and leadership competencies.
Monitor training KPIs and identify competency gaps, compliance risks, and improvement opportunities.
Support NPI, technology transfer,



and process implementation by ensuring personnel are properly trained and qualified.
Candidate Profile:
Bachelor’s degree in Industrial, Manufacturing, Quality, Mechanical, Electronics, Biomedical Engineering, or a related field.
7+ years of experience in regulated manufacturing environments.
3+ years of experience leading training teams, training systems, or QMS-related activities.
Proven experience in Class III medical device manufacturing, preferably catheter manufacturing.
Experience working within an ISO Class 8 cleanroom environment.
Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, GMP, training systems, and competency management.
Experience with LMS, training matrices, TWI/OJT, continuous improvement, and data analysis.
Advanced English proficiency (C1).

📌 Training Manager (Tijuana)
🏢 Foxconn Baja California
📍 Tijuana