Teamleiter Qualitätsmanagement (QMS) / Team Lead Quality Management Systems (m/w/d)
Core
Lead a small team to ensure the conformity, effectiveness, and continuous improvement of the Quality Management System (QMS) for medical devices.
Role type
Team Lead Quality Management Systems (QMS)
Builds
Medical device quality processes and audit outcomes
Domain
Medical Technology / Healthcare
Required skills
QMS management, internal and external audits, CAPA, training, document control, change control, regulatory compliance (ISO 13485, EU MDR, GMP/GxP), data analysis, team leadership, SAP
Preferred skills
Medical device industry experience, pharmaceutical industry experience, SAP expertise
Responsibilities
Ensure QMS conformity and continuous improvement; manage central QMS elements including audits, CAPA, training, and document control; prepare for and accompany audits and inspections; translate regulatory requirements into practical processes; analyze quality KPIs; support quality-relevant IT processes; lead and develop a small team.
Seniority
Manager, first-time or experienced team lead