Quality Manager Medical Devices / ISO 13485 (w/m/d)
Core
Managing and developing the quality management system for medical devices, ensuring compliance with ISO 13485 and supporting regulatory and post-market surveillance processes.
Role type
Quality Manager (Medical Devices)
Builds
Quality management systems and documentation for medical device manufacturing
Domain
Medical Devices / Regulatory Compliance
Required skills
ISO 13485, CAPA, Non-Conformities, Audit Management, Post-Market Surveillance, Vigilance, Regulatory Affairs
Preferred skills
EU-MDR, MDSAP, Regulatory Affairs
Technologies
ISO 13485, EU-MDR, MDSAP
Responsibilities
Managing and developing the quality management system, Planning and conducting internal and external audits, Steering NC, CAPA, and complaint processes, Supporting regulatory and quality-related questions, Collaborating with Development, Production, and Regulatory Affairs
Seniority
Mid-level, hands-on IC