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).

📌 Staff Training Coordinator (Tijuana)
🏢 Foxconn Baja California
📍 Tijuana