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ISO 13485 Lead Auditor - Remote

Posted 2 days ago
All others
Contract
USA

Overview

As an ISO 13485 Lead Auditor at RQM+, you will support various internal audits for clients in the U.S. while ensuring compliance with medical device regulations and standards.

In Short

  • Manage audit planning and execution within set timelines.
  • Provide mentorship while conducting audits.
  • Develop training modules for the Audit Practice.
  • Stay updated on new regulations and standards.
  • Engage in client-facing roles with confidence.
  • Handle challenging situations with tact and integrity.
  • Maintain high levels of integrity and customer focus.
  • Communicate effectively and proactively.
  • Work collaboratively within a cohesive team.
  • Embrace continuous improvement.

Requirements

  • Qualified ISO 13485 Lead Auditor with extensive experience.
  • MDSAP auditing experience required.
  • Experience with FDA 21 CFR Part 820.
  • Strong auditing skills in the Medical Device industry.

Benefits

  • Opportunity to work with a leading MedTech CRO.
  • Engage in meaningful work that impacts patient outcomes.
  • Collaborative and supportive team environment.
  • Continuous professional development opportunities.
RQM+ logo

RQM+

RQM+ is a leading MedTech service provider with the largest global team of regulatory and quality experts, boasting over 40 years of regulatory expertise. The company offers a wide range of services including clinical trials, lab services, and reimbursement support, aimed at reducing risk and facilitating market access for medical devices, digital therapeutics, and diagnostics throughout their product lifecycle. RQM+ collaborates with 19 of the top 20 medical device manufacturers and seven of the top 10 in vitro diagnostic companies, leveraging a team with extensive experience from regulatory bodies such as the FDA and MHRA. Committed to employee development and work-life balance, RQM+ values its workforce as its greatest asset.

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