Medical Device QMS Auditor

Location: Must be located in the US (Minnesota, Wisconsin, or Illinois)

BSI (British Standards Institution) is a global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.

Essential Responsibilities

• Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
• Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
• Recommend the issue, re‑issue or withdrawal of certificates, and report recommendations ...