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