Job Description The Quality Manager role has primary responsibility for supporting and managing the Quality Management System assisting with development and implementation of standard operating procedures in compliance with applicable FDA, ISO-13485, CE, and other regulatory certification requirements as well as with internal policies and objectives. Job Functions (Essential): Collaboration with cross-functional leads to establish quality specifications for all products and processes Ensure appropriate quality planning and procedures for new products, design changes and process modifications Establish tools to monitor quality processes and prepare reports of findings on a regular periodic basis and present at