Senior Training Manager - Class III Medical Devices & GMP

Foxconn Baja California

Tijuana

Presencial

MXN 900.000 - 1.200.000

Jornada completa

14 días+
Generador de candidaturas

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Descripción de la vacante

Foxconn Baja California is 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 role will lead the site’s training and competency management strategy, ensuring workforce qualification, regulatory compliance and operational readiness within a highly regulated manufacturing environment.

Formación

  • Bachelor’s degree in a relevant engineering/quality field.
  • 7+ years of experience in regulated manufacturing environments.
  • 3+ years leading training teams, training systems, or QMS activities.
  • Proven experience in Class III medical device manufacturing, catheter experience preferred.
  • Experience in ISO Class 8 cleanroom environments.
  • Strong knowledge of ISO 13485, FDA QMS requirements, GMP, and training systems.
  • 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

Training leadership
LMS
QMS
Data analysis
Compliance
Continuous improvement
Documentation
English proficiency

Educación

Bachelor’s degree in Industrial, Manufacturing, Quality, Mechanical, Electronics, Biomedical Engineering, or related field

Herramientas

LMS
Regulatory compliance tools
CAPA system
Root cause analysis

Descripción del empleo

Foxconn Baja California is 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 role will lead the site’s training and competency management strategy, ensuring workforce qualification, regulatory compliance and operational readiness within a highly regulated manufacturing environment.

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