Senior Training Specialist – Medical Device Manufacturing

About the role

The Senior Training Specialist develops, administers, and continuously improves training programs that support employee competence, product quality, and regulatory compliance in a medical‑device manufacturing environment. This role partners closely with Quality, Regulatory Affairs, Document Control, and functional leaders to ensure training effectiveness.

Key responsibilities

• Develop, implement, and maintain role‑based training curricula supporting regulatory, quality‑system, manufacturing, and job‑skill requirements.
• Administer day‑to‑day training‑system activities, including assignment of training, maintenance of learning records, and preparation of training reports.
• Partner with Document Control and change‑control stakeholders to assess training impacts and ensure personnel are trained on new or revised procedures before implementation.
• Collaborate with manufacturing, Quality, Regulatory Affairs, Engineering, and other functional leaders to identify training needs and align curricula with business requirements.
• Design and deliver new‑employee orientation and onboarding programs for in‑house personnel.

Required profile

• Strong knowledge of medical device manufacturing and quality‑system training requirements, including FDA regulations.
• Proven ability to develop practical solutions to complex training and compliance challenges and work independently under general direction.
• Excellent verbal and written communication skills with the ability to collaborate across all organizational levels.
• Strong organizational, analytical, database, and reporting skills with exceptional attention to detail.

Required skills

• Learning Management System (LMS) administration
• Electronic Document Management System (EDMS) usage
• Knowledge of FDA regulatory requirements for medical devices