Auditor (w/m/d)
Core
Lead and coordinate internal and external audits for medical device quality management systems, ensuring compliance with international regulations.
Role type
Quality Management Auditor (Medical Devices)
Builds
Audit management processes and compliance with global quality standards
Domain
Medical Devices / Quality Management Systems
Deliverable
dashboards & analysis
Required skills
Audit management, ISO 13485, EU MDR 2017/745, 21 CFR Part 820, IEC 60601, Technical documentation review
Preferred skills
Natural sciences degree, Project management, Digitalization of processes
Technologies
ISO 13485, MDR, 21 CFR Part 820, IEC 60601
Responsibilities
Design and conduct internal process and system audits, Coordinate external third-party audits, Manage corrective and preventive actions, Support global projects on quality process development
Seniority
Mid-level, hands-on IC