Fresenius Medical Care D. GmbH
Complaint Investigator(m/w/x)
Full-timeWith HomeofficeExperienced
Schweinfurt
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FRFresenius Medical Care D. GmbH
CAPA Expert(m/w/x)
Schweinfurt
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Leading CAPA investigations for medical devices improving kidney disease treatment. 3+ years CAPA management in international MedTech with strong ISO 13485, 21 CFR Part 820.100, EU MDR, GDP knowledge required. International project scope, cross-functional team collaboration.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Quality Management, or related technical field
- Minimum 3 years CAPA management experience in international MedTech industry
- Strong knowledge of ISO 13485, 21 CFR Part 820.100, EU MDR and GDP
- Analytical and problem-solving abilities with structured RCA methodologies
- Success in cross-functional collaboration and influencing stakeholders
- Organizational, communication, and project management skills
- Fluency in German and English
- Willingness to travel
Tasks
- Lead and manage CAPA investigations
- Ensure compliance and timely execution
- Identify root causes using problem-solving methods
- Define corrective and preventive actions
- Collaborate cross-functionally with operational teams
- Approve CAPAs and non-conformances
- Analyze data and evaluate trends
- Present outcomes to the Review Board
- Support audits and process improvements
- Implement new CAPA tools and methods
- Train and mentor staff across sites
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO 13485
- 21 CFR Part 820.100
- EU MDR
- GDP
- RCA methodologies
Benefits
Career Advancement
- Self-determined career planning
Learning & Development
- Professional development opportunities
Modern Office
- Innovative thinking room
Corporate Discounts
- Global corporation benefits
Informal Culture
- Collegial medium-sized company culture
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. GmbH 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.
Not a perfect match?
- DE01 DEU Fresenius Medical Care D. GmbH
Senior Director Verification & Test(m/w/x)
Full-timeWith HomeofficeManagementSchweinfurt - Fresenius Medical Care D. GmbH
Software Risk Manager(m/w/x)
Full-timeWith HomeofficeSeniorSchweinfurt - Fresenius Medical Care D. GmbH
Head of 5008 Verification(m/w/x)
Full-timeWith HomeofficeSeniorSchweinfurt - Fresenius Medical Care
Ingenieur Elektrotechnik/Informationstechnik für Funktechnologien(m/w/x)
Full-timeWith HomeofficeExperiencedSchweinfurt
FRFresenius Medical Care D. GmbH
CAPA Expert(m/w/x)
Schweinfurt
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Leading CAPA investigations for medical devices improving kidney disease treatment. 3+ years CAPA management in international MedTech with strong ISO 13485, 21 CFR Part 820.100, EU MDR, GDP knowledge required. International project scope, cross-functional team collaboration.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Quality Management, or related technical field
- Minimum 3 years CAPA management experience in international MedTech industry
- Strong knowledge of ISO 13485, 21 CFR Part 820.100, EU MDR and GDP
- Analytical and problem-solving abilities with structured RCA methodologies
- Success in cross-functional collaboration and influencing stakeholders
- Organizational, communication, and project management skills
- Fluency in German and English
- Willingness to travel
Tasks
- Lead and manage CAPA investigations
- Ensure compliance and timely execution
- Identify root causes using problem-solving methods
- Define corrective and preventive actions
- Collaborate cross-functionally with operational teams
- Approve CAPAs and non-conformances
- Analyze data and evaluate trends
- Present outcomes to the Review Board
- Support audits and process improvements
- Implement new CAPA tools and methods
- Train and mentor staff across sites
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO 13485
- 21 CFR Part 820.100
- EU MDR
- GDP
- RCA methodologies
Benefits
Career Advancement
- Self-determined career planning
Learning & Development
- Professional development opportunities
Modern Office
- Innovative thinking room
Corporate Discounts
- Global corporation benefits
Informal Culture
- Collegial medium-sized company culture
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. GmbH 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
Fresenius Medical Care D. GmbH
Industry
Healthcare
Description
The company is dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments.
Not a perfect match?
- Fresenius Medical Care D. GmbH
Complaint Investigator(m/w/x)
Full-timeWith HomeofficeExperiencedSchweinfurt - DE01 DEU Fresenius Medical Care D. GmbH
Senior Director Verification & Test(m/w/x)
Full-timeWith HomeofficeManagementSchweinfurt - Fresenius Medical Care D. GmbH
Software Risk Manager(m/w/x)
Full-timeWith HomeofficeSeniorSchweinfurt - Fresenius Medical Care D. GmbH
Head of 5008 Verification(m/w/x)
Full-timeWith HomeofficeSeniorSchweinfurt - Fresenius Medical Care
Ingenieur Elektrotechnik/Informationstechnik für Funktechnologien(m/w/x)
Full-timeWith HomeofficeExperiencedSchweinfurt