Training Manager

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).