2 days old
2018-05-242018-06-23

Quality Systems Manager

Terumo
Elkton, MD
  • Job Code
    377502
JobId: 377502
JobTitle: Quality Systems Manager
Department: Corporate_Compliance
Location: Elkton
Description: Job Summary:
This position is responsible for managing quality functions that sustain the infrastructure of the Quality System at both the corporate level and for all manufacturing sites.  S\/he is responsible for ensuring the effective establishment and maintenance of quality systems in order to comply with the applicable regulations of all countries in which Terumo Medical either manufactures or distributes products including, but not limited to the U.S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive.  
 
Job Details:
  1. Maintain and improve current quality system elements to ensure compliance of global medical device regulations pertaining to Quality Systems.
  2. Act as consultant in determining efficient and effective methods for meeting regulations.
  3. Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system along with providing individuals with professional growth.
  4. Ensure maintenance and implementation of requirements for quality processes, including operational oversight and continuous improvement for proactive quality management. Oversee quality system processes such as CAPA, software validation, distribution controls, etc.
  5. Establish strategic direction for the Corrective and Preventive Action program; including processing, monitoring, reporting and resolving CAPA improvements.
  6. May act as company representative for third party audits.
  7. Respond to customer inquiries and submission support.
  8. Facilitate the Quality System Training programs.
  9. Manage, administrate, implement quality system software.
  10. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit\/company performance improvement.
  11. Responsible to management of data and presentation of data to management in accordance with Management responsibility procedure.
  12. Performs other job related duties assigned.

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Quality Systems Manager

Terumo
Elkton, MD

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Terumo
Elkton, MD

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