QA-RA Specialist

1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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QA-RA Specialist

  • Specialty:

    Engineering
    • City:

      Kennesaw
    • State:

      GA
    • 30144
  • Assignment Type:

    Direct Hire
  • Job Id:

    49058
  • Payrate:

    $38.46

Description

QA/RA SPECIALIST
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.

RESPONSIBILITES

  • 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. 

QUALIFICATIONS

  • 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.  

  •  

Quick Apply

  • 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.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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