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.