Qms Engineer

Descripción y detalle de las actividadesDoc. 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. 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 complaintsExperiência y requisitosProfess. 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 Desired: Experience working with colleagues overseas in US, Europe and Asia. Billingual (English / Spanish)**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario** L-J: 7:00 a.m. - 5:00 p.m. V: 7:00 a.m. - 3:00 p.m.**Estudios** Titulo Profesional**Sexo** Indistinto**Disponibilidad p. viajar** Si