Sterile Device Packaging Auditor - Independent Contractor

This Sterile Device Packaging Auditor position is an excellent opportunity for recent retirees or consultants that have Medical Sterile Device experience in basic physical, mechanical and chemical properties of plastics and/or other materials, sterile device packaging, equipment, and process validation.

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.

The ideal auditor candidate will possess most of the following criteria:

• Minimum of five (5) years direct experience (Medical Sterile Device industry) in the following aspects: basic physical, mechanical and chemical properties of plastics and/or other materials; basic raw material testing methods; packaging procedures; storage, handling and environmental controls, to include clean room environments; facilities experience; processing of various plastics and/or other materials; tooling requirements; interim and final product testing, including sampling procedures; appropriate secondary operations (e.g., printing, labeling, cleaning); equipment and process validation.


• Minimum of five (5) years’ experience in sterile device packaging, preferably including several of the following:
  
  
  
  • Sterile barrier system formation
  
  
  • Sterile device packaging assembly
  
  
  • Sealing techniques
  
  
  • Also, potentially Sterilization techniques (e.g. gamma, ethylene oxide)
  
  
  
  


• Minimum of five (5) years of Quality Assurance/System experience preferably in the Medical Sterile Device industry and/or in the following areas:  conducting supplier audits, supporting internal and external audits, managing CAPA or non-conformances, and/or writing technical reports.


• Must have familiarity with ISO 11607-1 and ISO 11607-2


• Familiarity with one or more of the following: ISO 9001, ISO 13485, AC8004, ISO/TS 16775, ISO 14644-1, 21CFR820 (QSR), GHTF/SG3/N99-10:2004.


• Bachelor of Science (or equivalent) and/or ASQ certification(s).       


• Good technical understanding of manufacturing equipment/processes, including Product/Process Qualification/Validation, i.e., IQ, OQ, PQ.