Quality Auditor ISO 13485- Cleveland, OH (1099 Contractor)

Pro QC International North AmericaCleveland, OH
$35 - $50Onsite

About The Position

This is a 1099 contract role for a Quality Auditor with ISO 13485 certification or training. The primary responsibility is to conduct audits at client supplier manufacturing sites using Pro QC checklists. The role involves identifying risks and potential issues through process audits, classifying findings against ISO 13485 requirements, communicating with the audit team, and issuing audit reports on time. The current project is 2-4 days long, with potential for variation based on client needs. The role requires travel to Twinsburg, OH, and surrounding areas.

Requirements

  • ISO 13485 certified or trained
  • Manufacturing and operations background
  • Medical device expertise
  • 2–4+ years in quality management or medical device industry
  • Experience with QMS processes (CAPA, validation, design controls, etc.)

Responsibilities

  • Performing audits at the manufacturing sites of our clients' suppliers per Pro QC checklists.
  • Using the process audit to identify relevant risks and point out potential issues.
  • Looking at audit findings and classifying them against the ISO 13485 requirements.
  • Communicating findings with the audit team and issuing audit reports within the due date.
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