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Fresenius Medical Care D. GmbH
14d ago

CAPA Expert(m/w/x)

Schweinfurt
Full-timeWith Home OfficeExperienced

Description

You will drive quality excellence by leading CAPA investigations and root cause analyses. Your day-to-day involves collaborating across teams to ensure compliance while mentoring others on key processes.

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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

Education

Bachelor's degree

Work Experience

3 years

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

Tools & Technologies

ISO 1348521 CFR Part 820.100EU MDRGDPRCA methodologies

Languages

German – Business Fluent

English – Business Fluent

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.
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