Medical Device Quality Specialist

Milwaukee, WI

Job ID: 123369 Industry: Med

Medical Device Quality Assurance Specialist

Project Description:

Our client is a Medical Device company that produces MRI RF Coils and patient comfort devices. They are in need of a Quality Assurance Specialist to come in and assist with the daily operation and improvement of their Quality System.

Responsibilities:

This individual will be involved with the execution and improvement of all existing service, manufacturing and design quality systems across all functions. They will also be expected to engage in the improvement of documented policies and procedures throughout these functions. In regards to the overall Quality System, this person will engage in ensuring there is appropriate documentation, ensure Regulatory Compliance, and provide some expertise and training on how to control quality systems documentation. It will be expected of this person to approve CAPA’ s, investigations, deviations, and non-conformance dispositions. They must have the ability to perform Quality System Audits. They should also have a thorough understanding of Change Control so they may act as a part of a change control board.

Required:
  • Quality Assurance (7 years)
  • Document Control (5 years)
  • 21CFR820
  • ISO13485
  • CAPA
  • QMS Compliance for Medical Devices
  • GMP

 
  • Plus:
  •   BS Scientific, Technology, Clinical

Job Type: Contract  

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