CAPA Expert

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 , 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.