Job
- Level
- Senior
- Job Field
- BI, Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Jena
- Working Model
- Onsite
Job Summary
In this role, you will develop an effective quality management system for SAP implementation, plan risk management activities, and document compliance with regulatory requirements within the project.
Job Technologies
Your role in the team
- As Validation Manager Focus SAP Implementation (m/f/x), 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.
- 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 an interface for internal and external partners and support all activities regarding CSV.
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Our expectations of you
Education
- You have a completed university degree (Master's level) in natural sciences, engineering, business administration, or a comparable qualification.
Qualifications
- 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 are familiar with quality methods and tools such as FMEA, CAPA, 5-Why, and risk management.
- 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.
Experience
- You bring extensive years of professional experience in Quality Management within the medical device, pharmaceutical, or similarly regulated industry.
- You have proven experience with Computerised System Validation (CSV).
- You have valid experience with SAP and BPMN 2.0 is a plus.
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Benefits
Work-Life-Integration
Health, Fitness & Fun
Topics that you deal with on the job
Job Locations
This is your employer
Carl Zeiss AG
ZEISS is a world-leading technology company that is active in the fields of optics and optoelectronics. In the last financial year, ZEISS generated sales revenues of more than 6.4 billion euros through its four segments Semiconductor Manufacturing Technology, Industrial Quality & Research, Medical Technology and Consumer Markets (as at 30 September 2019).
Description
- Company Size
- 50-249 Employees
- Company Type
- Established Company
- Working Model
- Full Remote, Hybrid, Onsite
- Industry
- Industry, Production
Dev Reviews
by devworkplaces.com
Total
(1 Review)3.7
Culture
4.0Workingconditions
4.6Career Growth
3.6Engineering
2.7
Validation Manager Focus SAP Implementation
- Location
- Jena
- Working Model
- Onsite
- Diversity
- Open for all genders
