Validation Manager Focus SAP Implementation (m/f/x)

Seeing beyond - future of medical technology

Your Role

• You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements

• You ensure the compliant implementation and application of MED QMS requirements within SAP-supported processes in cooperation with partner teams

• You plan, drive, and document risk management activities across processes and projects

• You develop, implement, monitor, and document validation strategies for Computerised System, ensuring compliance with regulatory requierments

• You act as a subject matter expert and trusted advisor for quality and regulatory topics within cross-functional teams

• You act as interface for in and -external Partners and support all activities regarding CSV

Your Profile

• You have a completed university degree (Master’s level) in natural sciences, engineering, business administration, or a comparable qualification

• You bring extensive years of professional experience in Quality Management within the medical device, pharmaceutical, or similarly regulated industry

• You possess solid knowledge of quality management standards and regulatory frameworks, in particular ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements

• You have proven experience with Computerised System Validation (CSV)

• You are familiar with quality methods and tools such as FMEA, CAPA, 5-Why, and risk management

• You have valid experience with SAP and BPMN 2.0 is a plus

• You demonstrate a structured and analytical approach and are able to interpret complex technical and business information

• You work independently and in a solution-oriented manner with strong communication and organizational skills

• You are fluent in English; German language skills are an advantage

Your ZEISS Recruiting Team: