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Terumo Cardiovascular Group Director, Commercial & Supplier Quality in Ann Arbor, Michigan



Director, Commercial & Supplier Quality

Job Description:

This position is responsible for overseeing the quality and effectiveness of the Division supplier and contract manufacturing base. This position is responsible for providing the necessary support to the Commercial (customer facing) Organizations. This position is accountable to lead, develop and manage the correct functioning of the Supplier Quality Engineering team to achieve company goals in a timely manner. The Supplier Quality Engineering team acts as the quality liaison between Terumo and our suppliers, providing product and component quality requirements, maintaining required supplier controls, generating supplier quality data, trends, metrics and related reports and determining/monitoring the effectiveness of supplier 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. Responsible to provide direct customer and Commercial organizations support for Quality issues, information sharing, Quality System training, and supporting field actions where appropriate.

  3. Provide leadership, development and direction to the Supplier Quality Engineering team as well as communicate performance expectations.

  4. Provide leadership to cross-functional business partners for compliant creation and implementation of Supplier development strategies.

  5. Support execution of strategies that will improve the agility and reliability of the supply base.

  6. Identify and proactively work with strategic suppliers to ensure the delivery of continuous improvement ideas.

  7. Develop suppliers and define requirements to meet current quality requirements/expectations.

  8. Establish and maintain policies and procedures on the qualification of new supply sources, supplier quality relations, and reevaluation/maintenance of suppliers’ quality status.

  9. Ensure audits of suppliers' quality systems, quality capabilities, processes, and facilities are completed according to established requirements and schedules.

  10. Approve the addition/removal/re-evaluation of suppliers to the ASL through appropriate processes.

  11. Provide appropriate resources to determine and ensure suppliers meet all purchasing controls requirements. Review new and modified product designs from a material standpoint advising modifications when necessary.

  12. Accountable for the oversight and administration of Supplier Performance programs for material and corrective actions.

  13. Assist Materials Management and Engineering to resolve Supplier Review and Acceptance issues including appropriate risk review.

  14. Involve suppliers, internal resources, and plant personnel to drive containment and effective closure of supplier quality issues.

  15. Accountable for the generation of accurate and timely supplier quality data, trends, metrics, and related reports.

  16. Accountable and monitor the effectiveness of corrective and preventive actions to resolve non-conforming issues.

  17. Utilize 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.

  18. Perform other duties as assigned.

Terumo Cardiovascular Group is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.

EOE Minorities/Women/Disabled/Veterans

Auto req ID:



Terumo CV Group Ann Arbor, MI


Requires a four-year college degree and a minimum of ten years of experience in quality assurance, of which a minimum of five years must be leadership experience in a regulated environment or a Masters degree and a minimum of six years of experience in quality assurance. Certification from ASQ such as CQA and CQM/OE are preferred.

Department Name:

Supplier Quality EM