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.

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)

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

Travel Required: Most audits are conducted on-site at clients’ locations.
Physical Demands: Auditor is frequently required to walk and to sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. The auditor is occasionally required to stand; climb or balance; and stoop, kneel, crouch, or crawl. Work requires regular physical strain such as long periods of driving and flying. Specific vision abilities required by the job include close distance, distant vision, color vision, peripheral vision, depth perception, ability to hear and understand conversation in noisy environments and the ability to adjust focus.
Work environment: Exposed to a combination of normal office type environments and shop environments. The noise level in the work environment is usually moderate with regular exposure to shop elements such as very loud noise, moving parts, odor, dust, fumes, heat, cold or chemicals.
Personal Protective Equipment: The performance of this position regularly requires exposure to a typical manufacturing area, under certain conditions that may require the use of personal protective equipment such as safety glasses with side shields, mandatory hearing protection, steel toe shoes and hard hats.