Carl Zeiss Spectroscopy GmbH
Regulatory Affairs Experte(m/w/x)
Full-timeOn-siteSenior
Jena
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ZEZEISS medical technology
Quality Management System (QMS) Manager(m/w/x)
Jena
Full-timeOn-siteSenior
Nejo AI Summary
Developing and improving QMS for medical technology in ophthalmology and microsurgery, integrating requirements into SAP processes. Proven Computerised System Validation (CSV) experience and ISO 13485/MDR/21 CFR Part 11 knowledge essential. Work in a highly regulated medical technology environment.
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)
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
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- ISO 13485
- MDR
- 21 CFR Part 11
- Computerised System Validation (CSV)
- FMEA
- CAPA
- 5-Why
- SAP
- BPMN 2.0
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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ZEZEISS medical technology
Quality Management System (QMS) Manager(m/w/x)
Jena
Full-timeOn-siteSenior
Nejo AI Summary
Developing and improving QMS for medical technology in ophthalmology and microsurgery, integrating requirements into SAP processes. Proven Computerised System Validation (CSV) experience and ISO 13485/MDR/21 CFR Part 11 knowledge essential. Work in a highly regulated medical technology environment.
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)
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
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- ISO 13485
- MDR
- 21 CFR Part 11
- Computerised System Validation (CSV)
- FMEA
- CAPA
- 5-Why
- SAP
- BPMN 2.0
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.
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