Specialist Quality Management (m/w/d)
Core
Ensuring quality standards and regulatory compliance for rehabilitation and care products, including wheelchairs and mobility aids, across the entire product lifecycle.
Role type
Specialist Quality Management (Medical Devices)
Builds
Rehabilitation and care products (manual/electric wheelchairs, rollators, bath & WC aids)
Domain
Medical devices / Rehabilitation equipment
Required skills
Quality Management, ISO 13485, Regulatory requirements, Audit execution, CAPA management, Risk analysis, Process optimization
Preferred skills
Medical device Class 1 experience, Technical education with QM training
Technologies
Microsoft 365
Responsibilities
Coordinate internal and external quality-related issues, Monitor and develop the ISO 13485 quality management system, Plan and conduct internal and external audits, Create and maintain quality documents, Support management reviews and quality policy implementation, Analyze quality metrics and handle deviations/reclamations, Collaborate with development, production, and customer service teams
Seniority
Specialist, hands-on IC