Descripción y detalle de las actividadesEnsure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21 CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction.
Roles & Responsibilities: Prepares trend reports of PL's (Process Log) and Quality Notifications (VR's, NCR's, EE's) performing analysis of major offenders.
Follow up on Quality Notifications (VR's, NCR's, EE's) open for Mexicali and Corporate locations that affect assigned products (PDIA, History Check and Root Cause Analysis) Participates in the development of lines, process and / or products validations documenting their results in SAP or Agile systems.
Conducts improvement projects for defect reduction.
Performs mentoring activities for new quality engineers.
Comply with the Organization's Policies, Regulations and Code of Conduct.
Provides feedback clarifying quality controversies to Production Supervisors or FQI Technicians according to regulatory standards.
Participates in Customer Complaint investigations.
Reviews and approves validation protocols performed by Manufacturing Engineering documenting their results in SAP or Agile systems.Experiência y requisitosEducation: Bachelor's Degree.
Any engineering degree English language skills: English Advanced 80% Job or area experience: Quality Engineer or Manufacturing Engineer 5 years Experience in process validations Knowledge/skills: Lean Manufacturing Knowledge in ISO-13485, 21CFR820 Troubleshooting techniques (CAPA System, 5 why's, Fish Diagrams, 8 D's) or similar Six Sigma and statistical tools (MSA-Measurement System Analysis, DOE-Design Of Experiments, Process Capability, SPC-Statistical Process Control, PFMEA-Process Failure Mode and Effect Analysis)OrganizaciónIntuitive Surgical, S. de R.L de C.V.Correo de contactoGiroMaquiladora (Export.
)Actividad principalProductos médicos para cirugía.Número de empleados2000**Área** Calidad**Contrato** Permanente**Turno** Mixto**Jornada** Tiempo Completo**Estudios** Carrera Profesional**Inglés **Hablado: 80%, Escrito: 80%**Sexo** Indistinto