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Quality Assurance Specialist

Title:?Quality Assurance Specialist

Location:? Allendale, NJ

Duration:? 1/9/20

Requirements:

  • Minimum 2 to 3 years experience in a medical device industry completing the management of non-conformances and CAPA?s.
  • ?Proficient in Trackwise
  • Six Sigma trained ? Green Belt.
  • Expert with Root Cause Analysis techniques with proven use and application of those techniques.
  • Experience with the use of an electronic CAPA System.
  • Excellent data collection, management and reporting skills.
  • Knowledge of FDA & ISO regulations required.
  • Ability to work closely with engineers and other team members in understanding device functionality and surgical techniques in evaluating complaints for reportability purposes
  • Must be PC literate and have knowledge of Microsoft Office software

Responsibilities:

  • Mentor and facilitate CAPA owners on Investigations, Action Plans, and Verification/Validation Activities.
  • Ensure ?true? root cause is determined within investigations and all information is fact based with supported objective evidence.
  • Monitor Problem Statements, Containment, RCA, Corrections/CAs/PAs, time lines, and required updates.
  • Act as site Subject Matter Expert for Root Cause Analysis.
  • Chairing the Nonconformance Review Board meetings.
  • Lead NC/CAPA Team in monthly meetings.
  • Ensure all NC files are: established, maintained in a timely & organized manner, well documented, and closed properly.
  • Identify & trend appropriate metrics and present defined reports.
  • Complete and manage the internal audit program for the Division.
  • ?Conduct supplier audits, as needed.
  • Support Quality Systems in any additional activities within the department

 

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