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Sterilization Medical Device Auditor - Independent Contractor

REMOTE POSITION, USRemote

AI Summary

Conducts sterilization audits for medical devices, traveling domestically or internationally to evaluate Ethylene Oxide and Radiation sterilization processes against quality standards.

About this role

Overview

This Sterilization Medical Device Auditor position is an excellent opportunity for recent retirees or consultants that have Sterilization experience in Ethylene Oxide or Radiation(Gamma, Electron Beam &/or X-ray).

Our auditors enjoy traveling domestically and/or internationally, a flexible schedule (some auditors perform 1 or 2 audits a month, while others desire to audit every week), competitive compensation that includes a daily rate plus travel expenses, meeting new people and keeping in touch with technology and the latest developments, networking with other industry professionals.

To learn more about this auditor position, please review these General Guidelines.

Qualifications

The ideal auditor candidate will possess the following criteria:

  • Bachelor's Degree
  • Minimum of 3 years hands-on sterilization work experience in Ethylene Oxide or Radiation (Gamma, Electron Beam &/or X-Ray)
  • Knowledge of the Standards as they relate to Sterilization
  • Minimum of 5 years auditing experience (not necessarily sterilization)
  • Quality Assurance System experience (primarily ISO 13485 or 21CFR820)

Skills

21 CFR 820Electron Beam SterilizationEthylene Oxide SterilizationGamma Radiation SterilizationISO 13485Medical Device Sterilization StandardsQuality Assurance AuditingSterilization Process ValidationX-ray Sterilization

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