Manažer kvality (Quality Manager)

The Quality Manager provides strategic and operational leadership for the quality department, ensuring compliance with regulatory requirements such as 21 CFR § 820, ISO 13485, and EU MDR. This role oversees the quality management system (QMS), manages audits and CAPA processes, and drives continuous improvement initiatives using methodologies like Six Sigma and Lean Manufacturing. The position involves leading the quality team, collaborating across departments, and serving as a subject matter expert for internal and external stakeholders.