Assistenz / Assistent Qualitätsmanagement (w/m/d), Julius Zorn GmbH
Core
Supporting the maintenance and development of the Quality Management System (QMS) for a medical device manufacturer, ensuring compliance with ISO 13485 and regulatory requirements.
Role type
Quality Management Assistant
Builds
QMS documentation, audit support, risk management processes, and regulatory compliance measures for medical devices.
Domain
Medical Devices / Quality Management
Required skills
QMS documentation, audit preparation and follow-up, risk management, CAPA handling, validation support, regulatory requirement implementation
Preferred skills
ISO 13485 knowledge, experience in regulated environments (medical devices, pharma), commercial or technical training background
Technologies
MS Office
Responsibilities
Creating and maintaining QM documents (procedures, work instructions), preparing for internal and external audits, collaborating on risk management, handling deviations and complaints, supporting validations and qualifications, training employees on QM topics
Seniority
Junior, entry-level assistant