Senior Quality Systems Specialist

The Senior Quality Systems Specialist is responsible for supporting the maintenance and implementation of the Medical Device Quality Management system, and for developing and coordinating innovative solutions to quality, regulatory and operational-related activities. Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971:2019 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, and Current Good Manufacturing Practices (cGMP) are necessary. The Sr. Quality Systems Specialist supports strategic direction, establishes efficient and compliant processes throughout the organization, and has effective communication skills at all levels within the organization.