ISO 13485 Lead Auditor
RQM+Texas, United States
Posted October 16, 2025
Contract / Temporary
About the Company
RQM+ is The MedTech CRO, accelerating medical technology from innovation to patient impact. With expertise in regulatory compliance, quality systems, clinical trials, and reimbursement strategies, RQM+ partners with manufacturers to bring life-changing technologies to market faster and safer. Their tailored solutions ensure seamless product development and post-market support across various device types and therapeutic areas.
Job Description
RQM+ is a MedTech CRO specializing in regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies. They are seeking a Contract ISO 13485 Lead Auditor for internal audits of clients in Asia. The role involves project management, audit planning, client communication, and training on emerging regulations.
Requirements
- Professional and qualified Medical Device ISO 13485 Lead Auditor
- MDSAP auditing experience
- FDA 21 CFR Part 820 experience
- Fluent in English
- Robust auditing experience
- Behaviours: Maintain integrity, focus on customer success, improve continuously, communicate effectively, courageously address challenges, and operate as a cohesive team.
Benefits
- Industry leading compensation package
- Deeply ingrained focus on work life balance