Our client, the world's first developer of integrated, video-based digital medicine designed to help people living with cognitive impairment is looking for a Quality Systems Specialist to join its fabulous team.
Make a difference in the lives of many.
- Ensures the establishment and maintenance of a compliant and effective Quality Management System
- Responsible for executing processes and procedures under the QMS in areas such as document control, training, Internal audit, and standard operating procedure creation, maintenance, and revision.
- Supports the implementation of the Q&R processes providing leadership, support, and or guidance as requested.
- Ensures Q&R requirements are effective in all processes in scope of the role
- Ensures document control and the training program that is already established and compliant with applicable regulations (ISO 13485, FDA 21 CFR 820, etc.)
- Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Leads or assists with quality implementation plans for significant changes to the quality system.
- Supports quality system improvements including but not limited to the conversion of paper based processed to qualified and released electronic tools.
- Supports supplier management in line with established supplier management procedures.