CAPA Expert (mfd)

Schweinfurt - Germany

Monthly Salary: Not Disclosed

Posted on: 9 days ago

Vacancies: 1 Vacancy

Job Summary

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

Bachelors 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 ISOCFR 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.

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 Sy...