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Medical Device Auditor, CO

Medical Device Auditor, CO

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Medical Device Auditor, CO

Medical Device Auditor
Colorado, USA

Do you want to build on the experience you have and learn what it really takes to get a device on to the market? Have you ever considered working for a notified body? MSI Pharma are representing a market leading MDR/ IVDR designated notified body who continues to grow. We are looking for individuals who want to train to be a Lead Medical Device Auditor and benefit from industry leading training and development.

Medical Device Auditors, using their knowledge from industry and their training conduct audits for clients to ensure products meet international standards. The Medical Device Auditor is a client facing role and requires significant travel to client sites. We try to keep this travel to regional however your expertise could occasionally be used across the USA to support.

** For this position ** We are looking for candidates with hands on experience of active (electrical) or active implantable medical devices based in Colorado.

Core Responsibilities:

  • Deliver third-party audit services to assigned clients in accordance with regulatory requirements
  • Analyze quality systems and assess ISO 13485 and CE Marking
  • Manage a portfolio of assigned clients
  • Participate in professional development and training opportunities to achieve necessary certifications and statuses


  • Bachelors, Masters or PhD in relevant science or engineering
  • 4+ years medical device experience
  • Work experience can be within: Research and development, manufacturing, service, testing
  • 2+ years working in a quality management environment

This role would allow you to work with different products and different manufacturers almost daily. This notified body works with the biggest names to small start ups working on a product that is going to revolutionise the industry. No two days would be the same!