Qms Engineer
hace 2 semanas
Descripción y detalle de las actividades
Doc. Control Implementation and lead of local Doc Control according to own requirements and legal requirements, e.g.ISO 13485. Uploading new local docs in eDoc. Maintain local Quality Index. To review local QMS docs regarding Doc Con and GDP requirements. Support change management of manufacturing documents by leading Local change control board. CAPA To ensure local implementation of the global CAPA system according to regulatory requirements. To review CAPA and MIR Reports. To analyze CAPA status, to monitor KPIs and perform data analysis (QIT, MRB, KPIs,.). To work on global CAPA checks. To share local CAPAs and MIRs with global CAPA Officer or CAPA Board to discuss RCA or actions if needed. To provide evidences for implemented actions Training Support Localt trainig officer when required on: local implementation of the training concept according to global requirements, additional local regulatory requirements and according to ISO 13485 if needed. To analyze training status, to monitor KPIs / data analysis. Follow up on QMS training status. to add roles to employee account on eCampus. To enroll employees to local courses on eCampus. To provide training to employees on QMS and QA related topics Audit To prepare and to participate during internal audits (QMS) To prepare and to participate during external audits (QMS) Lead the system of Local in-process inspections by the execution and creation of audit reports Others Support, when needed, with creation and performing of local Management Review Keep tracking of actions driven by Management review and QIT To track status of costumer complaints
Experiência y requisitos
4+ years of experience in QMS experience Profess. Knowl.: GDP, Statistical Analysis, Six Sigma or similar, ISO 13485, Management of work teams, Methodologies: Presentation and Training Capabilities, GMP, Quality Control Soft Skills: Communication and Team Player English 80%+ Desired: Experience working with colleagues overseas in US, Europe and Asia.
Organización
WSA
Giro
Medicina
Actividad principal
Manufactura y Distribucion
Número de empleados
600
**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera Profesional
**Inglés **Hablado: 85%, Escrito: 85%
**Sexo** Indistinto
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