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CAPA Expert (m/f/d)
Fresenius Medical Care
Schweinfurt
On-site
EUR 60,000 - 80,000
5 days ago
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Web Shop Expert/ Product Expert
Xsolla
Germany
Remote
EUR 40,000 - 60,000
5 days ago
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Field Operations Manager (German-speaking)
Via
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On-site
EUR 40,000 - 55,000
5 days ago
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Head of Off Trade/Retail Germany
Diageo
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On-site
EUR 90,000 - 120,000
5 days ago
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Discover more opportunities than anywhere else. Find more jobs nowFinance Systems Data Analyst
Remote
Baden-Württemberg
Remote
EUR 27,000 - 70,000
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Senior Commercial Excellence and Pricing Manager MEAP/CIS/Russia (m/f/d)
Abbott
Wiesbaden
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EUR 60,000 - 80,000
5 days ago
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Connect with headhunters to apply for similar jobsHEAD OF IT INFRASTRUCTURE AND DATACENTER OPERATIONS – ITISC21
Eurofins USA BioPharma Services
Hamburg
On-site
EUR 70,000 - 90,000
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Senior Director Verification & Test (m/w/d)
Fresenius Medical Care
Schweinfurt
On-site
EUR 80,000 - 100,000
5 days ago
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Energy Commodity Buyer (m/f/d)
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EUR 55,000 - 75,000
5 days ago
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Senior Product Services Hedge Funds Analyst
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Manager Business Intelligence - Revenue Growth (f/m/d)
Jägermeister
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On-site
EUR 60,000 - 80,000
5 days ago
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Medical Excellence Manager (all genders)
Allergan Aesthetics
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On-site
EUR 60,000 - 80,000
5 days ago
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CLUSTER IT OPERATIONS MANAGER - GERMANY, AUSTRIA, SWITZERLAND, BELGIUM
Plastic Omnium
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On-site
EUR 80,000 - 100,000
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Product Center Manager (m/f/d)
Fresenius Medical Care
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On-site
EUR 70,000 - 90,000
5 days ago
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Omnichannel Manager (m/f/d) - Sales Enablement
GSK
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On-site
EUR 70,000 - 90,000
5 days ago
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Junior Site Reliability & Security Engineer (m/w/d)
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Germany
Hybrid
EUR 40,000 - 60,000
5 days ago
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HEAD OF IT INFRASTRUCTURE AND DATACENTER OPERATIONS – ITISC21
Eurofins USA
Hamburg
On-site
EUR 80,000 - 100,000
5 days ago
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Senior Program Manager HD Therapy System (m/w/d)
Fresenius Medical Care
Schweinfurt
On-site
EUR 70,000 - 90,000
5 days ago
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PMO & Business Excellence Speciality, Manager Job Details | STADA Arzneimittel AG
STADA
Bad Vilbel
Hybrid
EUR 70,000 - 95,000
5 days ago
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HEAD OF IT INFRASTRUCTURE AND DATACENTER OPERATIONS – ITISC21
Eurofins USA PSS Insourcing Solutions
Hamburg
On-site
EUR 80,000 - 100,000
5 days ago
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CAPA Expert (m/f/d)
Fresenius Medical Care
Schweinfurt
On-site
EUR 60.000 - 80.000
Full time
5 days ago
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Job summary
A leading medical technology company in Schweinfurt is seeking a CAPA Lead to manage investigations and collaborate with cross-functional teams. The role requires at least 3 years of CAPA management experience in the MedTech industry, strong analytical skills, and knowledge of regulatory standards like ISO 13485. Candidates should be fluent in German and English, and willing to travel when necessary. This position offers opportunities for professional development and impactful contributions to quality management.
Qualifications
- Minimum 3 years of CAPA management experience in MedTech.
- Strong knowledge of ISO 13485, 21 CFR Part 820.100, EU MDR and GDP requirements.
- Willingness to travel when required.
Responsibilities
- Lead and manage CAPA investigations, ensuring compliance and effectiveness.
- Apply structured problem-solving methods for corrective actions.
- Provide training and guidance on CAPA and NC processes.
Skills
CAPA management
Analytical skills
Problem-solving
Cross-functional collaboration
Project management
Communication skills
Education
Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related field
Job description
Requirements
- Lead and manage CAPA investigations, ensuring compliance, effectiveness, and timely execution.
- Apply structured problem-solving methods to identify root causes and define corrective and preventive actions.
- Act as CAPA Lead for assigned cases and collaborate cross-functionally with Quality Systems and operational teams.
- Perform Quality Approver activities for CAPAs and NCs in alignment with regulatory and internal requirements.
- Drive CAPA/NC reporting, data analysis, and trend evaluations, presenting outcomes to the CAPA Review Board and management.
- Support audits, inspections, and process improvements, including implementation of new CAPA tools and methods.
- Provide training, mentorship, and guidance on CAPA and NC processes across multiple sites.
Qualifications & Competencies
- Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related technical field.
- Minimum 3 years of CAPA management experience in the MedTech industry in an international environment.
- Strong knowledge of ISO 13485, 21 CFR Part 820.100, EU MDR and GDP requirements.
- Proven analytical and problem-solving abilities, including experience with structured RCA methodologies.
- Demonstrated success in cross-functional collaboration and influencing stakeholders.
- Strong organizational, communication, and project management skills with high attention to detail.
- Fluent in German and English; willingness to travel when required.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.