Mitarbeiter (m/w/d) Qualitätsmanagement (Chirurgische Instrumente)
Core
Maintaining, monitoring, and developing the Quality Management System (QMS) for medical devices, including documentation, audit preparation, and regulatory compliance.
Role type
Quality Management Specialist (Medical Devices)
Builds
QMS documentation and audit readiness for medical device products
Domain
Medical Technology / Regulatory Compliance
Required skills
QMS management, ISO 13485, MDR, audit preparation, documentation management, regulatory compliance, stakeholder communication
Preferred skills
Experience with medical device QMS, structured work style, customer-facing communication
Responsibilities
Maintain and update QMS documentation, prepare for internal and external audits, serve as a contact for clients on quality issues, support regulatory compliance (MDR), collaborate with production and sales teams