5 years of professional experience in Quality Management, Quality Assurance, or Process Improvement—ideally in a regulated environment * Drive process adoption and quality improvement initiatives in compliance with ISO 9001, ISO 13485, IVDR * Certification in Quality Management (e.g., ISO 13485, MDSAP, IVDR) * Proficient in continuous improvement and problem-solving methodologies (e.g., CAPA, 8D, FMEA, 5W, RPZ, Six Sigma, PDCA, STATISTIK)
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