8 days old

Sr. Supply Chain QA Engineer

Terumo
Toronto, OH 43964
Job Summary:

Develop and maintain a quality system for the Terumo Canada site that complies with Terumo Medical Corporations quality management system (QMS) and relevant regulatory requirements for the distribution of medical devices.

Job Details:
  • Ensures that the quality management system requirements are effectively established and effectively maintained in accordance with the requirements of Health Canada, Terumo Medical QMS and other applicable laws and regulations for the distribution center (DC).
  • Responsible for reporting on the performance of the DC quality system to management with executive responsibility for review.
  • Develop quality goals and objectives from the Quality Policy that are linked to the business plan. Communicate and implements the Quality Policy.
  • Oversee the management oversight, NC\/CAPA, validation, change control, risk management, internal\/supplier audits, calibration, document control\/records management, and training systems.
  • Manage\/control quality of product from receiving to distributing ensuring appropriate product conditions and traceability. Ensure nonconforming product is adequately segregated and appropriately controlled until dispositioned.
  • Communicate the importance of meeting customer requirements as well as regulatory requirements.
  • Sponsor and\/or lead quality improvement activities.
  • Manages the Internal and External Audit Programs. Liaison with internal and external contacts with regards to quality issues.
  • Interact with Health Canada relative to medical device reporting, establishment licensing, special access requests, and other regulatory related communications.
Posted: 2018-12-07 Expires: 2019-01-06
Sponsored by:
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Sponsored by:
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Sr. Supply Chain QA Engineer

Terumo
Toronto, OH 43964

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