Descripción y detalle de las actividades- Conducting activities to improve logistics processes - Support for the Head of distribution in Quality aspects - Management and development of local suppliers - Daily contact with partners and Quality Representatives on issues related to distribution quality. - Audit of logistics processes and performance of post-audit activities. - Preparation of quality reports. - Incoming quality inspection of goods - Analysis of customer data - Internal quality assurance of conducted processes: reviewing, auditing processes - Support in the implementation of the engineering changes - Cooperation with Process Engineers - assessment of the impact of introduced changes on product performance - Designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions. - Sustaining and lead local Document Control system according to own requirements and legal requirements, e.G. ISO 13485, FDA. - Maintain local overview of QMS documents - Support local QMS and Production change management process. - Ensure harmonization with global documents and requirements - Sustaining of the global CAPA system according to regulatory requirements (ISO 13485, FDA) - Review CAPA and MIR Reports regarding accuracy of root cause and actions - Train employees on CAPA topics (CAPA phases, RCA, etc.) if needed - Analyze CAPA status, to monitor KPIs and perform data analysisExperiência y requisitos- 2+ years of experience in quality engineering, quality assurance, or a similar role. - University degree in Industrial or Mechanical Engineering is required - Analytical thinking, collaboration and problem solving are crucial skills for Quality Engineers. Meeting regulatory requirements takes thorough, careful analysis of information and maintaining the highest quality of standards. - Experience coding and using QA software tools and processes. - 2+ years in quality area and experience in regulations, or a similar roleOrganizaciónWSAGiroMedicinaActividad principalManufactura y DistribucionNúmero de empleados600**Área** Ingeniería**Contrato** Permanente**Turno** Nocturno**Jornada** Tiempo Completo**Horario** L-J: 5:00 p.M. - 2:00 a.M. v: 3 p.M. - 11 p.M.**Estudios** Titulo Profesional**Sexo** Indistinto