Plastics Medical Device Processing Auditor - Independent Contractor

This Plastics Medical Device Auditor position is an excellent opportunity for recent retirees or consultants that have experience in Plastics Injection Molding, Plastics Extrusion Molding and/or Plastic Mechanical Assembly.

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 hands on experience (Plastics Medical Device industry, injection molding, extrusion and/or mechanical assembly preferred) in the following aspects of plastics and related materials: basic physical, mechanical and chemical properties of plastics and related 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 related materials; tooling requirements; interim and final product testing, including sampling procedures; appropriate secondary operations (e.g., de-flashing, slitting); equipment and process validation. 
• Minimum of five (5) years’ experience (Plastics Medical Device industry preferred) in at least injection molding and/or preferably in several of the following:
• Plastics Injection Molding: Insert Molding, Overmolding, Injection Blow Molding, Transfer Molding and Compression Molding
• Plastics Extrusion: Tubing/Profile Extrusion, Sheet/Film Extrusion, Blown Film Extrusion, Over-Jacketing Extrusion, Coextrusion and Ram Extrusion
• Plastics Mechanical Assembly: Adhesives/Bonding, Mechanical Fasteners, Plastics Welding, Heat Staking.
• Minimum of five (5) years of Quality Assurance experience preferably in the Plastics Medical Device industry and/or in the following areas: conducting supplier audits, supporting internal and external audits, managing CAPA or nonconformances, or writing technical reports.
• Familiarity with one or more of the following: ISO 9001, ISO 13485, 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.