ISO 13485 Lead Auditor - Remote

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.