QA-RA Specialist

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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QA-RA Specialist

  • Specialty:

  • Title:

    QA/RA Specialist
    • City:

    • State:

    • Zip Code:

  • Start date:

  • Status:

  • Assignment Type:

    Direct Hire
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We have an immediate need for a QA/RA Specialist with a medical device company in Kennesaw, GA. This is a direct hire opportunity with a salary and benefits. The QA/RA Specialist will assist in completing various quality and regulatory tasks relevant to medical device manufacturing and distribution.


  • Assist in preparation for applicable FDA, ISO, and internal audits.
  • Maintain training files for employees.
  • Develop and track relevant fiber manufacturing Quality Management metrics.
  • Perform CAPA activities (i.e. review proposed corrective actions, effectiveness checks).
  • Assist in updating documents through redline, DCO administration, document receipt/verification tracking and applicable personnel training relative to document changes.  
  • Serve as CAPA Administrator and assist in complaint handling processes including file maintenance, complete complaint investigations, complaint trending and complaint file closure. 


  • Bachelor’s degree in Biomedical or Mechanical Engineering, Business or related area.
  • 2+ Years of experience within the medical device industry. 
  • Knowledge of quality tools/sampling plans/problem solving/statistical process control/design of experiments.  
  • Knowledge of ISO 13485:2016 and/or FDA 21 CFR 820 experience 
  • Relevant experience in Quality Assurance, Regulatory Affairs, Compliance or Development in an FDA regulated environment.  


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