Qualitätsmanager / QM-Beauftragter (m/w/d)
Core
Ensuring and strategically developing the quality management system for medical device products (Spine, Trauma, Dental) in compliance with regulatory standards.
Role type
Quality Manager (Medical Devices)
Builds
Medical device products (Spine, Trauma, Dental)
Domain
Medical Technology / Regulatory Compliance
Required skills
Quality Management, ISO 13485, MDR (EU) 2017/745, 21 CFR Part 820, Audit Management, CAPA Management, Supplier Evaluation, Risk Analysis, Document Control, Regulatory Compliance
Preferred skills
Strategic planning, Process optimization, Stakeholder communication
Technologies
EN ISO 13485, MDR (EU) 2017/745, 21 CFR Part 820
Responsibilities
Maintain and develop the quality management system, oversee operational quality management (CAPA, supplier evaluation), conduct risk analyses, plan and execute internal and external audits, coordinate with external authorities.
Seniority
Mid-Senior, hands-on IC