Summary/objective
The Learning & Development (L&D) Trainer is responsible for coordinating, delivering, and documenting onboarding and job-specific training for production and quality employees within a medical device manufacturing environment. Reporting through the Quality Department, this role ensures all manufacturing personnel are trained and qualified in accordance with company procedures, and quality system standards.
The L&D Trainer partners closely with Quality, Manufacturing, Engineering, and Operations leaders to develop a highly skilled workforce capable of producing safe, effective, and compliant medical devices. The primary focus of this role is new hire onboarding, manufacturing process training, qualification management, and continuous improvement of training programs for line workers.
Essential functions
Onboarding & New Hire Training
- Facilitate onboarding programs for all new manufacturing and quality employees.
- Deliver training on company policies, quality culture, GMP (Good Manufacturing Practices), safety requirements, and manufacturing procedures.
- Ensure new hires complete required training and qualification activities within established timelines.
- Coordinate onboarding schedules with Production Supervisors, Human Resources, and Quality.
- Conduct training effectiveness assessments and provide feedback to employees and supervisors.
Manufacturing Training & Qualification
- Work with area Subject Matter Experts (SMEs) to train production employees in manufacturing processes, equipment operation, assembly procedures, inspection methods, and documentation practices.
- Evaluate employee competency through observation, practical demonstrations, written assessments, and certification activities.
- Organize employee training matrices and qualification records and provide to Quality for storage and retention.
- Requalify employees as required due to process changes, quality events, or periodic certification requirements.
- Support cross-training initiatives to improve workforce flexibility and production efficiency.
Quality & Compliance
- Maintain accurate and audit-ready training documentation.
- Support internal and external audits by providing training records and evidence of employee competency.
- Participate in investigations, CAPAs, and quality improvement initiatives involving training effectiveness.
- Assist with implementation of revised procedures, work instructions, and quality system requirements.
Training Development
- Work with Instructional Designer to develop and update training materials, work instructions, job aids, presentations, and qualification guides.
- Create engaging learning experiences tailored to adult learners in a manufacturing environment.
- Collaborate with Subject Matter Experts (SMEs) to ensure training content remains accurate and current.
- Analyze training data and identify opportunities for process improvement and performance enhancement.
- Support implementation and administration of learning management systems (LMS) as applicable.
Competencies
- Knowledge of quality systems (ISO 9001, ISO 13485, 21CFR 820 or similar)
- Strong documentation and organizational skills
- Strong communication and follow-up skills
Supervisory responsibilities
Required education and experience
- Associate’s or Bachelor’s degree
- 3+ year’s experience in an L+D or training related role
Physical demands & Travel required
- Frequent standing and walking on the manufacturing floor.
- Ability to observe and demonstrate manufacturing processes and equipment usage.
- Occasional lifting of training materials and equipment up to 25 pounds.
- Ability to wear required personal protective equipment (PPE) and work in a cleanroom or controlled manufacturing environment as required.
No travel required
