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.