Terumo Cardiovascular Systems Manager, Quality Operations in Ann Arbor, Michigan

em/emspan id="Job Description" class="TEXT"This position is responsible for managing production quality processes and staff to ensure compliance with global regulatory requirements, manufacturing standards, and internal procedures in order to facilitate site in producing safe and effective products. This position also has the authority to perform as the Deputy site Management Representative. 1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 2. Manage, maintain, and drive continuous improvement in the control of non-conforming product process. 3. Serve as Program Manager for zero defect initative. 4. Ensure product specifications and product acceptance are met and DHRs are accurate prior to product release. 5. Ensure compliance, review and approve documentation and records related to all elements of the quality system, with a focus on providing support required for production and process controls, controls of non-conforming product, corrections and removals, CAPA, change control, identification and traceability, and verification and validation. 6. Prepare and analyze quality data as required. Provide input data, including trending data, for production and process controls for site and for Management Review. 7. Manage and control materialroduct stored in Quarantine areas. 8. Support product and process CAPAs, NCRs and HHE investigations. 9. Participate in all FDA, Notified body, customer ,and other third party Quality audits as required 10. Participate in internal audits as required. 11. Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs. 12. Perform other duties as assigned./span