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

ZEISS Group; München; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

ZEISS Group in Munich is looking for a Validation Manager focused on SAP Implementation. You will be responsible for developing and maintaining an effective Quality Management System while ensuring compliance with medical device regulations.

The ideal candidate holds a Master's degree and has extensive experience in Quality Management within regulated industries. A strong understanding of ISO 13485, MDR, and Computerised System Validation is crucial for this role.

Fluent English is necessary; German skills are a plus. This is a unique opportunity to contribute to the ZEISS FIT4 SAP S/4Hana Project.

Qualifikationen

• Completed university degree (Master’s level) in a relevant field.
• Extensive professional experience in Quality Management within regulated industries.
• Solid knowledge of quality management standards and regulatory frameworks.

Aufgaben

• Develop, maintain, and improve the Quality Management System in compliance with ISO 13485 and MDR.
• Ensure compliant implementation and application of MED QMS requirements.
• Plan, drive, and document risk management activities across projects.

Kenntnisse

Quality Management

Regulatory Compliance

Computerised System Validation (CSV)

Risk Management

ISO 13485

MDR

Analytical Skills

Communication Skills

SAP

BPMN 2.0

Ausbildung

Master's degree in natural sciences, engineering, or business administration

Jobbeschreibung

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

As a Validation Manager, you are responsible for establishing, maintaining, and continuously developing an effective Quality Management System in compliance with applicable medical device regulations. The focus of the role is the coverage of Computerised System Validation (CSV) and the correct consideration of regulatory requirements within the implementation phase of ZEISS FIT4 SAP S/4Hana Project.

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 requirements.
• 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

Jana Benn, Sabrina Rieker