Karl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Full-timeWith HomeofficeNot specified
Tuttlingen
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KAKarl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Tuttlingen
Full-timeWith Home Office
Nejo AI Summary
Optimizing PLM information structures and documentation for regulatory compliance in the healthcare sector. Proven knowledge of DHF, DMR, and global regulatory standards (ISO 13485, FDA) required. 30 vacation days, special payments.
Requirements
- Completed degree in natural sciences or engineering
- Proven knowledge of DHF, DMR, and global regulatory standards (e.g., ISO 13485, FDA)
- Ability to define, optimize, and maintain information structures and documentation processes in PLM
- Ability to organize documentation, prepare audits, ensure transparent project structure
- Confident manner as contact for auditors and project teams, including audit coordination and interdisciplinary collaboration
- Very good English skills
- In-depth knowledge of IEC 60601-1 and electronic components for medical device compliance
Tasks
- Continuously optimize PLM information structures.
- Continuously optimize PLM documentation processes.
- Continuously optimize PLM templates.
- Ensure regulatory compliance in PLM.
- Ensure operational efficiency in PLM.
- Maintain complete DHF and DMR.
- Ensure DHF and DMR accuracy.
- Ensure DHF and DMR compliance.
- Own Project Data Plan per regulatory standards.
- Own Phase Gate checklists per quality objectives.
- Develop lean, transparent, and comparable project structures.
- Maintain lean, transparent, and comparable project structures.
- Immediately report missing DHF/DMR elements.
- Immediately report time-critical DHF/DMR elements to project manager.
- Provide guidelines for updating legacy product documentation.
- Ensure efficient compliance for legacy products.
- Ensure project documents are complete.
- Ensure project documents are up-to-date.
- Ensure project documents are audit-compliant.
- Act as main contact for auditors.
- Coordinate audit preparation.
- Represent development projects during audits.
- Process anomalies from predecessor products.
- Process anomalies from similar products.
- Integrate safety into requirements management system.
- Integrate quality into requirements management system.
- Apply IEC 60601-1 standards.
- Apply knowledge of electronic components.
- Ensure electrical safety of medical devices.
- Ensure performance of medical devices.
- Ensure compliance of medical devices.
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- PLM
Benefits
Flexible Working
- Hybrid work
- Flexible working hours
- Mobile working
More Vacation Days
- 30 vacation days
Bonuses & Incentives
- Special payments
Learning & Development
- Further training opportunities
- In-house seminar program
- E-learning offering
- Professional development courses
Corporate Discounts
- Corporate benefits
Company Bike
- Bicycle leasing
Retirement Plans
- Subsidy for private pension plan
Healthcare & Fitness
- Company health management
- Health activities
- Sports activities
Childcare
- Childcare options
Team Events
- Cultural activities
- Leisure activities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Karl Storz SE & Co. KG 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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KAKarl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Tuttlingen
Full-timeWith Home Office
Nejo AI Summary
Optimizing PLM information structures and documentation for regulatory compliance in the healthcare sector. Proven knowledge of DHF, DMR, and global regulatory standards (ISO 13485, FDA) required. 30 vacation days, special payments.
Requirements
- Completed degree in natural sciences or engineering
- Proven knowledge of DHF, DMR, and global regulatory standards (e.g., ISO 13485, FDA)
- Ability to define, optimize, and maintain information structures and documentation processes in PLM
- Ability to organize documentation, prepare audits, ensure transparent project structure
- Confident manner as contact for auditors and project teams, including audit coordination and interdisciplinary collaboration
- Very good English skills
- In-depth knowledge of IEC 60601-1 and electronic components for medical device compliance
Tasks
- Continuously optimize PLM information structures.
- Continuously optimize PLM documentation processes.
- Continuously optimize PLM templates.
- Ensure regulatory compliance in PLM.
- Ensure operational efficiency in PLM.
- Maintain complete DHF and DMR.
- Ensure DHF and DMR accuracy.
- Ensure DHF and DMR compliance.
- Own Project Data Plan per regulatory standards.
- Own Phase Gate checklists per quality objectives.
- Develop lean, transparent, and comparable project structures.
- Maintain lean, transparent, and comparable project structures.
- Immediately report missing DHF/DMR elements.
- Immediately report time-critical DHF/DMR elements to project manager.
- Provide guidelines for updating legacy product documentation.
- Ensure efficient compliance for legacy products.
- Ensure project documents are complete.
- Ensure project documents are up-to-date.
- Ensure project documents are audit-compliant.
- Act as main contact for auditors.
- Coordinate audit preparation.
- Represent development projects during audits.
- Process anomalies from predecessor products.
- Process anomalies from similar products.
- Integrate safety into requirements management system.
- Integrate quality into requirements management system.
- Apply IEC 60601-1 standards.
- Apply knowledge of electronic components.
- Ensure electrical safety of medical devices.
- Ensure performance of medical devices.
- Ensure compliance of medical devices.
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- PLM
Benefits
Flexible Working
- Hybrid work
- Flexible working hours
- Mobile working
More Vacation Days
- 30 vacation days
Bonuses & Incentives
- Special payments
Learning & Development
- Further training opportunities
- In-house seminar program
- E-learning offering
- Professional development courses
Corporate Discounts
- Corporate benefits
Company Bike
- Bicycle leasing
Retirement Plans
- Subsidy for private pension plan
Healthcare & Fitness
- Company health management
- Health activities
- Sports activities
Childcare
- Childcare options
Team Events
- Cultural activities
- Leisure activities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Karl Storz SE & Co. KG 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
Karl Storz SE & Co. KG
Industry
Healthcare
Description
Das Unternehmen ermöglicht Karrieren und fördert langfristige Beziehungen.
Not a perfect match?
- Karl Storz SE & Co. KG
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SQA Engineer(m/w/x)
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Quality Management Specialist(m/w/x)
Full-timeWith HomeofficeNot specifiedMühlheim an der Donau, Tuttlingen, Freiburg im Breisgau, Fridingen an der Donau - Aesculap AG
Software Requirements Engineer(m/w/x)
Full-timeWith HomeofficeExperiencedTuttlingen