Position Overview:

The Quality Operations Manager will manage site-level Quality System compliance, ensuring full compliance of the site quality System with US FDA, ISO 13485, MDSAP/MDR and other applicable country specific regulatory requirements. Specific focus will be on QC testing, documentation review, and product release. This position will also perform role of Site Quality System Deputy Management Representative and Safety Officer. Includes responsibility to ensure processes needed for the Quality management System (QMS) and safety are documented reporting to top management on the effectiveness of the QMS and safety and any improvement and ensuring promotion of awareness of applicable regulatory requirements and QMS requirement throughout the organization.

Responsibilities: