Senior Training Lead - Medical Device Manufacturing (ISO 8)

Foxconn Baja California; Baja California; Presencial; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Foxconn Baja California seeks an experienced training leader for its Class III medical device manufacturing site. You will own the training system, manage competency and records, and drive regulatory alignment in ISO 8 cleanroom production.

Required are 7+ years in regulated manufacturing, 3+ years leading training teams or QMS activities, and advanced English (C1). Experience with LMS, matrices, and data analysis is essential for ongoing GxP readiness.

Formación

• Bachelor's degree in Industrial, Manufacturing, Quality, Mechanical, Electronics, Biomedical Engineering or related field.
• 7+ years of experience in regulated manufacturing environments.
• 3+ years leading training teams, training systems, or QMS activities.
• Experience in Class III medical device manufacturing and ISO Class 8 cleanroom.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, GMP.
• Advanced English proficiency (C1).

Responsabilidades

• 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.

Conocimientos

Leadership

Training strategy

Regulatory compliance

Data analysis

Competency management

English proficiency

Educación

Bachelor's degree in Industrial/Manufacturing/Quality/Mechanical/Electronics/Biomedical Engineering

Herramientas

LMS

TWI/OJT

Training matrices

Data analysis tools

Descripción del empleo

Foxconn Baja California seeks an experienced training leader for its Class III medical device manufacturing site. You will own the training system, manage competency and records, and drive regulatory alignment in ISO 8 cleanroom production.

Required are 7+ years in regulated manufacturing, 3+ years leading training teams or QMS activities, and advanced English (C1). Experience with LMS, matrices, and data analysis is essential for ongoing GxP readiness.