Qualitätsmanager Medizintechnik / QMB (m/w/d)
Core
Ensuring and strategically developing the quality management system for medical devices in compliance with ISO 13485, MDR, and FDA regulations.
Role type
Quality Management System (QMS) Manager for Medical Devices
Builds
Quality management processes and compliance frameworks for surgical suction and drainage systems
Domain
Medical Devices / Regulatory Compliance
Required skills
ISO 13485, MDR (EU) 2017/745, FDA 21 CFR Part 820, audit coordination, risk analysis, CAPA management, change control, supplier evaluation
Preferred skills
Experience with FDA QSR, internal and external audit execution, stakeholder communication
Technologies
ISO 13485, MDR, FDA 21 CFR Part 820
Responsibilities
Maintain and develop QMS per ISO 13485/MDR/FDA; coordinate with external auditors and authorities; approve changes and perform risk assessments; manage daily QM operations including CAPA and incident handling; plan and conduct internal/external audits.
Seniority
Mid-Senior, hands-on IC