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Quality System Coordinator

Santa Clara,CA

 

Job Responsibilities:

 

The Quality Management System Coordinator facilitates the development, implementation, monitoring, and sustaining of a strong Quality Management System.

 

  • Revises Procedures, Work Instructions, and other QMS documentation, as needed.
  • Liaison with external auditors for ISO and other regulatory audits.
  • Coordinates the training program and maintains the training records
  • Performs Internal audits and initiates corrective actions and follow-ups to audit findings (i.e. ISO 9001, AS9100, & ISO 13485).
  • Collects the input from all departments for the management review, and present in the meeting
  • Prepares the minutes of meeting for the output of the MRM
  • Prepares Quality Reports per customer needs, prepares presentations, and fills out customer surveys-audits.
  • Coordinates and manages the root cause analysis and corrective action for the quality system related non-conformances
  • Monitors the Quality Objectives and KPIs defined by the organization.
  • Work as MRB coordinator and monitor timely closure of NCMRs with proper disposition.
  • Coordinates the calibration activity.
  • Perform frequent audits on the production floor and lead the continuous improvement
  • Performs other duties and tasks assigned by Quality head.

Education & Experience

  • College graduate or 2+ years of experience in Quality Management System.
  • Experience in EMS and IPC Certification is plus

Skills:

  • Strong knowledge of ISO 9001
  • Knowledge of ISO 13485, and AS9100 is a plus
  • Excellent in Microsoft Excel, Word, and Power Point.
  • Fluent in English

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