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QA Specialist II

Lake County, Illinois 60045

Category: Professional Job Number: 17416
 
Voca has an immediate opening available for a QA Specialist II in Lake County, ILInterested candidates will forward current resume to Stephen Olson at solson@myvoca.com and call 952-303-8113. Thanks!
Position Details 
Job Description:
Core Job Responsibilities 
  • Responsible for implementing and maintaining the effectiveness of the quality system. 
  • Review medical complaints, document filing decision rationale, and submit medical event reports in compliance with FDA regulations (21CFR803 and 21CFR820) and International Regulatory requirements within the required timeframes. 
  • Ensure medical event file documentation is clear, concise, and adheres to compliance requirements. 
  • Identify any nonconformances or potential nonconformances in a timely manner, ensure thorough documentation, and aid in the development of comprehensive CAPA strategies to prevent recurrence.
  • Provide subject matter expertise to the Customer Service and Support and Quality organizations responsible for identifying and resolving potential medical, clinical and /or safety issues. 
 

Qualifications
Education Requirements
  • Bachelors Degree in a scientific discipline or Certification in Medical Technology (AMT, MLT, or similar) preferred. Skills and Experience Required
  • Knowledge of regulations and standards affecting IVDs and Biologics.
  • Minimum of 3 years experience in either medical technology laboratory environment, or with IVD products through technical support, complaint handling, or similar work experience required.
  • Exemplary writing skills required; proficient use of MS Office and general IT system knowledge is a must.

Voca: The Spirit of Work
IND-SO

Stephen Olson

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