Quality Systems Coordinator

Quality Systems Coordinator

Quality Systems Coordinator

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Accentuate Staffing is actively seeking a Quality Systems Coordinator for a medical technology company in Durham. The ideal candidate for this direct hire lead the quality process initiation and follow up through closure of key indicators such as change notice, nonconformance and CAPA. You will manage the Electronic Document Control System and collect and data for reporting on key metrics to management and monitoring for status of quality related processes.

Responsibilities:

  • Responsible for monitoring and follow up with owners on quality documents such as change notices, CAPA and nonconformance to drive for timely completion.
  • Maintain logs used to track and trend training, change notice, nonconformance, CAPA, deviations and rework activities.
  • Communication of monthly trending status to management
  • Manage the Electronic Document Control System
  • Ensure that company procedures are followed and review documents for accuracy and compliance to standards.
  • Lead teams as subject matter expert for adherence to quality procedures and processes
  • Coordinate training as needed throughout the organization.
  • Participate in internal audits and external agency inspections.
  • Perform other Quality Systems duties as required to ensure compliance

Requirements:

  • Associates Degree in Science, Technology, or Business
  • Minimum of 2 Years’ Experience in Quality Document Administration or Coordination
  • Experience working in an FDA regulated environment required
  • Must have a “hands-on” approach and work effectively on cross-functional teams to establish and maintain appropriate processes pertaining to Quality
  • Excellent attention to detail, well organized and able to work independently and with a team.
  • Excellent organizational and time management skills and excellent written and oral communication skills.
  • Working knowledge of document control activities, training management, and cGMP / cGDP

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