(Senior) Manager Quality (m/w/d) Leiter Qualitätswesen Medizinprodukte Kosmetik
Core
Lead the strategic and operational management of the entire Quality department (Quality Management, Quality Assurance, Quality Control) for a global mid-sized company producing regenerative medical and skincare products.
Role type
Senior Manager, Quality Systems & Operations
Builds
A modern, data-driven quality organization that serves as a competitive advantage for medical and skincare products.
Domain
Medical Devices / Skincare / Regulated Manufacturing
Required skills
Quality Management Systems (QMS), ISO 13485, ISO 9001, GMP, Risk Management, CAPA, Change Control, Regulatory Compliance (MDR, IVDR, FDA), Audit Management, Process Optimization, Digitalization of Quality Processes, Statistical Analysis
Preferred skills
Leadership in regulated industries (Medical Devices, Pharma, Diagnostics), Building and developing QMS from scratch, Experience with internal/external audits
Technologies
QMS software solutions, Digital documentation tools
Responsibilities
Ensure compliance with regulatory requirements and ISO standards; Transform quality functions into a data-driven organization; Lead internal and external audits; Drive digitalization and efficiency of quality processes; Manage CAPA, Change Control, and Risk Management systems.
Seniority
Senior, Hands-on Manager
