JENOPTIK AG
Quality Assurance Specialist(m/w/x)
Full-timeOn-siteExperienced
Jena
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ZE
ZEISS medical technologyQuality Management System (QMS) Manager(m/w/x)
Jena
Full-timeOn-siteSenior
Description
You will drive the evolution of the company's Quality Management System while ensuring regulatory compliance and CSV excellence during the transition to SAP S/4Hana.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Master's degree in natural sciences, engineering, business administration, or comparable qualification
- •Extensive professional experience in Quality Management within regulated industries
- •Knowledge of ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements
- •Proven experience with Computerised System Validation (CSV)
- •Familiarity with FMEA, CAPA, 5-Why, and risk management
- •Experience with SAP and BPMN 2.0 (advantageous)
- •Structured and analytical approach to complex information
- •Independent, solution-oriented work style with strong communication
- •Fluency in English and German skills (advantageous)
Education
Master's degree
Tasks
- •Develop and maintain the Quality Management System
- •Improve the QMS per ISO 13485 and MDR standards
- •Implement MED QMS requirements within SAP-supported processes
- •Collaborate with partner teams on process implementation
- •Plan and document risk management activities
- •Develop and monitor validation strategies for computerized systems
- •Advise cross-functional teams on quality and regulatory topics
- •Coordinate CSV activities with internal and external partners
Tools & Technologies
ISO 13485MDR21 CFR Part 11Computerised System Validation (CSV)FMEACAPA5-WhySAPBPMN 2.0
Languages
English – Business Fluent
German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ZEISS medical technology and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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ZE
ZEISS medical technologyQuality Management System (QMS) Manager(m/w/x)
Jena
Full-timeOn-siteSenior
New Job?Nejo!
The AI Job Search Engine
Description
You will drive the evolution of the company's Quality Management System while ensuring regulatory compliance and CSV excellence during the transition to SAP S/4Hana.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Master's degree in natural sciences, engineering, business administration, or comparable qualification
- •Extensive professional experience in Quality Management within regulated industries
- •Knowledge of ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements
- •Proven experience with Computerised System Validation (CSV)
- •Familiarity with FMEA, CAPA, 5-Why, and risk management
- •Experience with SAP and BPMN 2.0 (advantageous)
- •Structured and analytical approach to complex information
- •Independent, solution-oriented work style with strong communication
- •Fluency in English and German skills (advantageous)
Education
Master's degree
Tasks
- •Develop and maintain the Quality Management System
- •Improve the QMS per ISO 13485 and MDR standards
- •Implement MED QMS requirements within SAP-supported processes
- •Collaborate with partner teams on process implementation
- •Plan and document risk management activities
- •Develop and monitor validation strategies for computerized systems
- •Advise cross-functional teams on quality and regulatory topics
- •Coordinate CSV activities with internal and external partners
Tools & Technologies
ISO 13485MDR21 CFR Part 11Computerised System Validation (CSV)FMEACAPA5-WhySAPBPMN 2.0
Languages
English – Business Fluent
German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ZEISS medical technology and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ZEISS medical technology
Industry
Healthcare
Description
ZEISS medical technology drives progress in ophthalmology and microsurgery, helping to maintain and improve people's vision and enable targeted interventions on diseased tissue.
Not a perfect match?
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