Validation Manager Focus Sap Implementation (m/f/x)
Zeiss Group
Computerised system validation csv experience
Iso 13485 and mdr regulatory knowledge
21 cfr part 11 compliance expertise
The role focuses on establishing and maintaining a Quality Management System compliant with medical device regulations during the SAP S/4Hana implementation
Job Summary
The role focuses on establishing and maintaining a Quality Management System compliant with medical device regulations during the SAP S/4Hana implementation.
You will act as a subject matter expert for quality and regulatory topics while driving risk management activities across projects.
This position requires extensive experience in Quality Management within the medical device or pharmaceutical industry to ensure compliant system validation.
Matching Summary
The role focuses on establishing and maintaining a Quality Management System compliant with medical device regulations during the SAP S/4Hana implementation.
Skills & Requirements
Must-have
Computerised System Validation CSV experience
ISO 13485 and MDR regulatory knowledge
21 CFR Part 11 compliance expertise
SAP S/4Hana implementation support
Risk management activities planning
Nice-to-have
BPMN 2.0 process modeling skills
German language proficiency
Cross-functional team collaboration
FMEA and CAPA methodology application
Key Requirements
Master's degree in natural sciences or engineering
Extensive years of professional experience in Quality Management
Valid experience with Computerised System Validation (CSV)
Solid knowledge of ISO 13485, MDR, and 21 CFR Part 11