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