eResearchTechnology GmbH
Technical Product Manager(m/w/x)
Full-timeOn-siteExperienced
Estenfeld
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CLClario
Sr Product Quality Engineer(m/w/x)
Estenfeld
Full-timeOn-siteExperienced
Nejo AI Summary
Ensuring medical devices and solutions meet global regulations and QMS compliance. 5+ years in GMP/GCP regulated environments required. Flexible working hours, professional development support.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or equivalent
- At least 5 years of Design Controls or Quality Management Systems experience
- At least 5 years of GMP and/or GCP regulated environments experience
- Agile development support in regulated environment experience
- Minimum 2 years of ISO and/or GCP standards experience
- Auditor experience in GCP/GMP environment preferred
- Strong troubleshooting, communication, and stakeholder management skills
- Professional working proficiency in English
- Willingness to travel internationally
Tasks
- Establish and maintain Clario's Quality Management System (QMS)
- Continuously improve Clario's Quality Management System (QMS)
- Provide quality and regulatory expertise
- Ensure devices and solutions meet global regulations
- Ensure compliance with control processes across projects
- Review development and technical documentation
- Provide quality and regulatory guidance
- Ensure medical and non-medical devices comply with regulations
- Contribute to product reviews
- Contribute to design control activities
- Support validation activities
- Resolve quality issues with internal departments
- Support continuous improvement initiatives
- Support the Quality Management designee
- Participate in quality surveillance activities
- Support revision of procedures and policies
- Support maintenance of procedures and policies
- Support internal audit activities
- Support external audit activities
- Serve as a member of the Designated Complaint Unit (DCU)
- Fulfill DCU responsibilities
- Report project status to management
- Report project risks to management
- Report project deviations to management
- Report quality concerns to management
- Recommend corrective actions
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible working hours
Family Support
- Work-life balance support
Learning & Development
- Professional development support
- Internal and external training
- Certification programs
Other Benefits
- Employee programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Clario 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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CLClario
Sr Product Quality Engineer(m/w/x)
Estenfeld
Full-timeOn-siteExperienced
Nejo AI Summary
Ensuring medical devices and solutions meet global regulations and QMS compliance. 5+ years in GMP/GCP regulated environments required. Flexible working hours, professional development support.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or equivalent
- At least 5 years of Design Controls or Quality Management Systems experience
- At least 5 years of GMP and/or GCP regulated environments experience
- Agile development support in regulated environment experience
- Minimum 2 years of ISO and/or GCP standards experience
- Auditor experience in GCP/GMP environment preferred
- Strong troubleshooting, communication, and stakeholder management skills
- Professional working proficiency in English
- Willingness to travel internationally
Tasks
- Establish and maintain Clario's Quality Management System (QMS)
- Continuously improve Clario's Quality Management System (QMS)
- Provide quality and regulatory expertise
- Ensure devices and solutions meet global regulations
- Ensure compliance with control processes across projects
- Review development and technical documentation
- Provide quality and regulatory guidance
- Ensure medical and non-medical devices comply with regulations
- Contribute to product reviews
- Contribute to design control activities
- Support validation activities
- Resolve quality issues with internal departments
- Support continuous improvement initiatives
- Support the Quality Management designee
- Participate in quality surveillance activities
- Support revision of procedures and policies
- Support maintenance of procedures and policies
- Support internal audit activities
- Support external audit activities
- Serve as a member of the Designated Complaint Unit (DCU)
- Fulfill DCU responsibilities
- Report project status to management
- Report project risks to management
- Report project deviations to management
- Report quality concerns to management
- Recommend corrective actions
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible working hours
Family Support
- Work-life balance support
Learning & Development
- Professional development support
- Internal and external training
- Certification programs
Other Benefits
- Employee programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Clario 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Clario
Industry
Healthcare
Description
The company transforms lives by unlocking better evidence to advance clinical science and bring life-changing therapies to patients faster.
Not a perfect match?
- eResearchTechnology GmbH
Technical Product Manager(m/w/x)
Full-timeOn-siteExperiencedEstenfeld - eResearchTechnology GmbH
Lead Engineer, R&D Software Quality(m/w/x)
Full-timeOn-siteManagementEstenfeld - DE1645 Prysmian Projects Germany GmbH
Project Quality Manager(m/w/x)
Full-timeOn-siteExperiencedWürzburg - Bertrandt
Systemtestingenieur in der Medizintechnik(m/w/x)
Full-timeOn-siteExperiencedWürzburg - eResearchTechnology GmbH
R&D Technical Architect(m/w/x)
Full-timeOn-siteExperiencedEstenfeld