At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products. Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.
This position is responsible for working between Terumo and our suppliers, providing guidance on product and component quality requirements; generating accurate and timely supplier quality data, trends, metrics and related reports; and determining and monitoring the effectiveness of corrective and preventive actions to resolve non-conforming issues.
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. Participate in audits at suppliers sites, covering quality system and production line capability so that a recommendation can be made on their ability to produce and deliver product. Responsible for assessment and audit reports along with recommendations, so other functions at Terumo may make appropriate decisions on selection.
3. Outline and communicate first article inspection requirements.
4. Prepare monthly quality data for scorecard evaluation.
5. Work within Terumo's NCR and SCAR process. This will include working with the supplier and various affected departments within Terumo towards the timely implementation and the verification of effectiveness of corrective actions using. Quality incident resolution may require site visits to a supplier's facility to better understand the particular issue and provide feedback to other Terumo team members.
6. Execute, jointly with supplier, continuous improvement programs.
7. Meet with Terumo management to ensure consistency of supplier status and problem resolution.
8. Attend Supplier Performance Reviews as needed.
9. Represent the Supplier Quality organization on cross-functional teams as needed.
10. When necessary, act as project leader (or assist in) for factory transfer projects so that all requirements and specifications are clearly communicated to the supplier.
11. Gather and review all documents required for the selection process.
12. Communicate to the potential supplier the selection requirements so that the process is understood by the supplier.
13. Manage and review monthly quality data for yields, trending, and process controls. Communicate to the supplier all results and provide feedback to quality engineers of data results so that the ongoing performance of the supplier can be measured.
14. Request Supplier Corrective Action plan from supplier, based on negative-trending issues from monthly quality data reports. This will include working jointly with the supplier for improvement, resolution and the verification of effectiveness of corrective actions undertaken.
15. Act as liaison between supplier and quality engineers and customer service when Terumo issues Corrective Actions due to rejected goods at incoming inspection or manufacturing or from customer complaints, so that improvements and corrective actions can be implemented and monitored.
16. When necessary, quality incident resolution may require immediate site visits to a supplier's facility to understand the particular issue more and to provide timely feedback to other Terumo team members.
17. Execute, jointly with supplier, continuous improvement programs such as SPC, DOE, PFMEA, Gage R&R, and Control Plans.
18. Perform on-going audits of suppliers' production lines to ensure conformity to Terumo requirements.
19. As part of the overall product qualification process, validate product performance to ensure it meets published specification and performance criteria.
20. Attend regularly scheduled conference calls with Terumo management to ensure consistency of supplier status and problem resolution.
21. May attend periodic Supplier Performance Reviews.
22. May represent the quality organization on cross-functional teams.
23. Perform other duties as assigned.
Requires a four-year college degree in an engineering or applied science discipline and a minimum of five years of engineering experience in Quality, Engineering, or Manufacturing within regulated industry. Intermediate computer software skills, i.e. Microsoft Office.
