Performance Review Institute

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Plastics Medical Device Processing Auditor

Plastics Medical Device Processing Auditor


More information about this opportunity


Use your auditing and manufacturing/engineering skills by partnering with the Performance Review Institute (PRI), a not-for-profit trade organization that is committed to the continual improvement of quality in critical industries.
The purpose of this independent contractor position is to conduct Plastics Injection Molding, Plastics Extrusion  and related audits. With the audit results reported back to key global Plastics Medical Device industry experts, who manage the audit and accreditation process, this position plays an important role in risk mitigation, supply chain oversight and continual improvement within the Plastics Medical Device industry. This varied and autonomous role would suit someone who has experience and/or qualifications in manufacturing/engineering/quality and is looking for a new challenge.


As an independent contract auditor, you will enjoy:
• Contributing to the continual improvement of Plastics Injection Molding quality in the global Plastics Medical Device industry
• Developing your own knowledge and skills by observing the many creative and innovative ways in which companies interpret and comply with customer requirements and industry specifications
• Staying on the cutting edge of technology by attending an annual auditor conference to hone your skills
• Managing your own schedule, choosing how often, when and where you conduct audits
• The opportunity to experience different cultures by auditing all over the world
• The security of having your schedule (and income) confirmed months in advance, while remaining independent, enabling you to organize other activities at your discretion
• Being associated with a respected, industry-managed organization with a history of commitment to quality excellence and an ongoing dedication to the continual improvement of the Plastics Medical Device supply chain


Being an auditor involves:
• Ensuring adequate pre-audit preparation including contacting the company ahead of time to arrange an audit timetable and reviewing documentation provided by the company
• Conducting the audit based on an industry-approved checklist including a review of the procedures, work instructions, training records and other documentation that evidences the competency of the company to meet customer requirements and observing real part processing through job audits to ensure that the documented requirements are properly flowed down to and implemented on the shop floor
• Holding regular meetings with the auditee during the audit for the purpose of transparency so that all parties understand the audit timetable and any findings identified
• Submitting an audit report to PRI staff in which any audit findings are clearly and logically documented
• Representing PRI to our customers by acting professionally at all times
• Working collaboratively with PRI staff and customers to organize audit schedules that meet the needs of all stakeholders
• Liaising with PRI’s preferred travel agency to organize a cost-effective travel schedule


To qualify to work as an auditor, applicants must meet the following general requirements:
• One to five (1-5) years of auditing experience preferred
• Understanding of what it means to work as an independent contractor and willingness to engage with PRI in this capacity
• Commitment to preserving the integrity of the program, maintaining strict confidentiality, and to avoiding all conflicts of interest
• Willingness to travel and conduct audits
• Written and oral proficiency in the English language
• Strong interpersonal skills


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

  • Minimum of five (5) years direct experience (Plastics Medical Device industry, injection molding and/or extrusion 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
  • 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, AC8004, 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.


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