ISO 13485 Lead Auditor
RQM+Georgia, 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 seeking an Independent Auditor to support their Global Audit Practice, focused on European clients. This role involves managing audits, identifying training needs, maintaining knowledge of regulations, and leading client meetings. The ideal candidate is professional, confident, and able to handle challenging client interactions while upholding integrity and achieving results.
Requirements
- Professional Medical Device ISO 13485 Lead Auditor with extensive auditing experience.
- MDSAP auditing experience.
- FDA 21 CFR Part 820 experience.
- Fluent in German and English.
Benefits
- Competitive Compensation Package
- Work Life Balance Focus