Develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements
Ensure the compliant implementation and application of MED QMS requirements within SAP-supported processes in cooperation with partner teams
Plan, drive, and document risk management activities across processes and projects
Develop, implement, monitor, and document validation strategies for computerized systems, ensuring compliance with regulatory requirements
Act as a subject matter expert and trusted advisor for quality and regulatory topics within cross-functional teams
Serve as the interface for internal and external partners and support all activities related to Computerised System Validation (CSV)

Completed university degree (Master’s level) in natural sciences, engineering, business administration, or a comparable qualification
Several years of professional experience in Quality Management within the medical device, pharmaceutical, or similarly regulated industry
Solid knowledge of quality management standards and regulatory frameworks, in particular ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements
Proven experience with Computerised System Validation (CSV)
Familiarity with quality methods and tools such as FMEA, CAPA, 5-Why, and risk management
Hands-on experience with SAP and BPMN 2.0 is a plus
Structured and analytical approach with the ability to interpret complex technical and business information
Ability to work independently and solution-oriented with strong communication and organizational skills
Fluent in English; German language skills are an advantage

Validation Manager – SAP Implementation

Key skills