CAPA Expert (m/f/d)

Fresenius Medical Care; Schweinfurt; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CAPA management

Analytical skills

Problem-solving

Cross-functional collaboration

Project management

Communication skills

Ausbildung

Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related field

Jobbeschreibung

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.