Mitarbeiter Qualitätswesen (m/w/d)
Core
Maintaining and documenting the Quality Management System (QMS) for medical devices and supporting colleagues in regulatory implementation.
Role type
Quality Management Specialist (Medical Devices)
Builds
QMS documentation and regulatory compliance reports for medical device products
Domain
Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Quality Management Systems (ISO 13485), Internal Audits, Regulatory Requirements (MDR), Data Protection Management, English (fluent), Office Applications
Responsibilities
Maintain and document the QMS per DIN EN ISO 13485, Plan and conduct internal audits, Create regular reports for management on QMS effectiveness, Implement regulatory requirements per MDR, Coordinate data protection management