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Job Number: 2169231

Quality Assurance Coordinator

To $80K

The primary duty of a Quality Assurance Coordinator is to maintain and continuously improve the effectiveness of the Quality Management System. This included establishing, implementing, and maintaining processes necessary for the QMS. Is also responsible to ensure that the QMS is in conformance with appropriate regulatory standards and requirements throughout the organization, as such the Quality Coordinator interacts with a number of company operations, including Sales, Engineering, Customer Service, Marketing, Production, and Human Resources. This position is directly related with several quality-related processes, as outlined below. This role requires a high degree of initiative and self-motivation.

Responsibilities: include, but are not limited to the following:

  • Review the management of CAPA (Including follow-up and assurance that the objective evidence of efficacy is captured)
  • Review and management of the customer feedback and complaint process
  • Review and management of the Risk Management Process
  • Review and assess manufacturing procedures
  • Identify Quality Issues
  • Execution of Internal Audits
  • Execution of Functional Testing
  • Maintain Awareness of regulatory changes and notify appropriate personnel of make necessary changes to maintain compliance
  • Develop and distribute professional and formal response to customer-reported quality problems
  • Seek and exploit opportunities to improve the QMS
  • Maintains current knowledge of government and industry compliance standards
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance
  • Technical writer
  • Develops and maintains auditing schedules.
  • Performs other duties as assigned by the Quality Manger

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