· Supports the administration of the Learning Management System (LMS) and management for the Quality System Training Program to ensure employees are trained to perform their activities.

· Provides Subject Matter Expertise on the learning process including learning management system to other functional areas.

· Ensures effective communication, monitoring and promotion of learning activities.

· Liaises with Division, Managers and Team Leaders to continuously improve learning processes and/or systems.

· Establishes and maintains a direct and proactive relationship with internal and external customers, has a strong understanding of current customer needs, anticipates and addresses issues, escalating as applicable.

· Authors and reviews learning documentation/material.

· Supports audit readiness to ensure successful audit inspection results related to the Learning system and/or processes.

· Ensures training program meets quality standards.

· Coordinate and support completion of training programs that are required to meet cGMP requirements.

· Maintains applicable administrative procedures and policies to ensure compliance with business process and regulatory expectations.

· Conduct training curriculum reviews and revise training plans accordingly

· Create and assist with the development of training materials.

· Coordinating resources (other presenters/instructors, course materials, training space, etc.),

· Create/manage a qualified train the trainer program

Basic Qualifications | Education:

· BS in preferably in Education, Science Engineering, Human Resources, Business, Instructional Design, or related discipline or equivalent combination of education and experience.

· 2-5 years experience in the medical device or regulated industry preferred.

· Demonstrated proficiency using MS Word, PowerPoint, and Excel

Preferred Qualifications:

· Familiar with federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD/IVDR

· Knowledge of adult learning delivery techniques and general principles of adult learning a plus.

· Ability to think strategically and provide direction to the management team along with the capacity to balance both short term and long term issues effectively.

· Preparing and delivering presentations

· Requires strong written and verbal communication skills.

· Requires strong organizational and time management skills, and the ability to prioritize multiple responsibilities and projects.

· Requires ability to deal appropriately with regulatory agencies.

· Requires working knowledge of training requirements required by regulatory agencies (documentation, effectivity, etc.)

· Must be able to work independently under minimal supervision.

· Must follow standard safety policies and procedures.

· Experience utilizing word processing software (e.g. MS Office - Word, Excel and PowerPoint)