Description:
This role is required to assess and provide a clear global vision of Quality Management System (QMS) document control and training compliance across the Teleflex organization through driving strategy, creation, direction, management, and oversight of these global programs.
Principal Responsibilities
- Ensuring that global document control and training systems meet applicable requirements, regulations, and standards, including but not limited to Regulations for Australia, Brazil, Canada, Japan, United States FDA 21 CFR and European Medical Device Directive, EU MDR, and ISO 13485
- Provide strategic oversight to the global QMS document control, and training program through roadmap and detailed plan creation
- Identify and implement Key Performance Indicators to reflect process effectiveness, speed and efficiency of global document control, and training systems
- Global implementation of Learning Management System (LMS) platform aligned with QMS training strategy
- Interface with all sites and site stakeholders for technical assistance and problem solving in areas of document control, and training
- Provide supervision and training, as required for site training personnel to manage QMS training.
- Lead and manage direct reports to perform necessary tasks for global document control, and training. Support direct reports in gaining knowledge of applicable standards, regulations, procedures, and work instructions to execute daily tasks and in support of individual development plans
- Lead and manage additional activities as assigned by direct supervisor or executive leadership
Education / Experience Requirements
- Experience working with Compliance Wire and Agile software
- Demonstrated expertise with developing and leading strategic improvement plans to business process flows
- Experience and/org ability to manage cross-functional team meetings, train and coach employees and give presentations
- Ability to establish rapport with internal and external customers, peers, and employees at all levels of organization