Manager Quality Systems (w/m/d)
Core
Lead the Quality Engineering team and drive the continuous improvement of the Quality Management System (QMS) for a medical device company specializing in 3D-tracking technology.
Role type
Manager, Quality Systems
Builds
Quality Management System (QMS) compliant with ISO 13485 for medical device manufacturing and tracking solutions
Domain
Medical Technology / 3D-Tracking
Required skills
Team leadership, QMS management, ISO 13485, Audit planning and execution, CAPA management, Root cause analysis, SOP development, Change management, Data analysis
Preferred skills
Regulatory Affairs collaboration, Dot Compliance, Epicor, Statistical process control, Cross-functional project leadership
Technologies
Dot Compliance, Epicor, MS Office
Responsibilities
Lead and develop the Quality Engineering team; Maintain and improve the QMS; Develop and update SOPs and process descriptions; Plan and execute internal, supplier, and customer audits; Manage the CAPA process and non-conformance handling; Analyze QMS metrics and lead quality improvement projects
Seniority
Manager, hands-on leadership
