Support the deployment and continuous improvement of the global quality training program’s governance model, business integration, Learning Management System (LMS), and compile & communicate program metrics for Management Review. Promote internal and external (i.e. FDA QSR/cGMP ISO 13485) training requirements while fostering a collaborative atmosphere of quality awareness.
Essential Job Functions:
- Plan and direct assigned Quality Training system activities with the accountability for successful completion of assigned deliverables related to;
- Ensuring job-based training requirements are effectively assigned, executed and managed across the organization
- Identify technical and/or process issues to determine root cause, propose recommendations and develop strategies for improvement to fill skill/competency gaps in meeting the minimum established LMS and associated Training requirements.
- Effectively support and or maintain the integration of the global training program infrastructure with LMS functionality
- Evaluate and communicate the effectiveness of training delivery through development of meaningful metrics; partner with area leadership to improve training effectiveness measures
- Develop global training specific processes, documentation and enforcement of standard procedures and practices; as well as providing ongoing LMS Front-end user support for the organization
- Other duties assigned by Leadership
- Bachelor’s Degree with a minimum of 8 years of applicable experience; OR Master’s Degree with a minimum of 6 years of applicable experience
- Experience with instructional methods and training techniques, including curriculum design principles and learning strategies
- Experience with Learning Management System administration, including course deployment, content management, e-Learning, user support, system & analytical reporting, and technical documentation.
- Learning Management System implementation experience is a strong plus
- Quality experience within the medical device industry is preferred
- Understanding of medical device requirements (e.g., QSR and ISO 13485)
- Excellent computer skills, including understanding and usage of MS Office
- Excellent problem solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Strong attention to detail
- Excellent written and verbal communication skills
- Dedicated to quality client service, pro-active and responsive to client needs
- Excellent interpersonal relationships building skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Strong Leadership skills and demonstrated ability to influence change
- Proven success adhering to and leading project schedules and managing sections of projects
- Extensive understanding of quality procedures while defining team-operating standards and ensuring essential procedures are followed based on related knowledge.
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
- Ability to work and excel within a fast paced, dynamic and constantly changing work environment
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines.