- Define global Complaints process as PO - Define global CAPA process as PO - Power user for ETQ reliance: accountable for user rights, roles and data evaluation within software tool - Perform trainings for related tools and processes - Contribution in project planning derived from CAPAs - Assist employees in handling and proceeding with CAPAs and Action Items - Coordinates global meeting of stakeholder parties - Verification of action items, approval of action plans and Request for CAPAs, especially with focus on coherence and comprehensiveness - Checks observance of due dates - Create effective CAPA Plan for authorities in conjunction with Regulatory Affairs and other stakeholders - Successfully completed studies (bachelor’s degree or equivalent education) in engineering, medicine or pharmacy or another relevant discipline - At least 4 years of professional experience in QM in a highly regulated environment, ideally medical technology - Experience with QM documentation and process descriptions and complaints processes - Analytical and structured way of working - Experience with international cooperation - Good communication, presentation and assertiveness skills
Global CAPA Manager (Ingenieur/in - Medizintechnik)