Senior Quality Management Professional (m/f/d)
Core
Senior Quality Management Professional supporting the international Quality Management System (QMS) for medical devices and pharmaceuticals, ensuring regulatory compliance and inspection readiness.
Role type
Senior Quality Management Professional (Medical Devices/Pharma)
Builds
International QMS for Medical Devices and pharmaceutical quality requirements
Domain
Healthcare / Medical Devices / Pharmaceuticals
Required skills
Quality Management Systems (QMS), Medical Device regulations, GxP (GMP/GDP), ISO 13485, MDSAP, Regulatory inspections, Audit management, Cross-functional project leadership, ERP systems
Preferred skills
German language skills
Technologies
MS Office, ERP systems
Responsibilities
Drive implementation and maintenance of international QMS; Provide guidance to business areas on QMS implementation; Ensure regulatory compliance and inspection readiness; Prepare for and follow up on regulatory authority and certification audits; Manage certifications (MDSAP, ISO 13485); Coordinate strategic initiatives; Engage stakeholders for consistent QMS implementation; Support management oversight and reporting on Q metrics; Conduct internal and external audits.
Seniority
Senior, hands-on IC
