Mitarbeiter Qualitätsmanagement (m/w/d)
Core
Supporting the Integrated Management System for a medical device company, focusing on ISO 13485 compliance, CAPA, and supplier management.
Role type
Quality Management Specialist (Medical Devices)
Builds
Quality management processes and regulatory compliance for medical devices
Domain
Medical Technology / Digital Health
Required skills
ISO 13485 knowledge, CAPA management, audit planning and execution, supplier evaluation, technical documentation management, change control
Preferred skills
Experience in regulated environments, knowledge of regulatory requirements in healthcare
Technologies
ISO 13485, Integrated Management Systems
Responsibilities
Managing and developing the Integrated Management System with focus on ISO 13485, handling complaints and deviations, planning and participating in internal audits, supporting external audits and certifications, managing supplier evaluation and monitoring
Seniority
Mid-level, hands-on IC