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 analysis
Experiência 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 role
Organización
WSA
Giro
Medicina
Actividad principal
Manufactura y Distribucion
Número de empleados
600
**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