Roles & Responsibilities:Use Personal Protective Equipment.Participates in the emergency brigades and Health and Safety commission, when required.Use devices, accessories, tools, and equipment according to the process; verifying that they arein good conditions of use and reporting those that are in poor condition for repair.Communicates unsafe acts or conditions to their superiors.Participates in the Health and Safety courses established by the Company.Maintains order and cleanliness in the workstation (5's) under your responsibility.
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.Completes the assigned trainings in ISU (Intuitive Surgical University) curriculumPrepares performance self-assessment for the MERIT process.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.Performs formal escalation process (Escalation Decision Form) or report nonconforming product, when required.Follows up on quality problems of recurring raw material.Participates in the activities of preparation of Audits and its development.QualificationsSkills, Experience, Education, & Training:Education: Bachelor's Degree Any engineering degreeEnglish language skills: English AdvancedSystem management: Office Package AdvancedSAP System IntermediateMinitab Intermediate - DesiredKob or area experience: Quality Engineer or ManufacturingEngineer 5 yearsExperience in process validations 5 yearsExperience in quality audits for medical products 3 yearsHave worked in the medical industry 3 yearsKnowledg/skills: Lean Manufacturing 3 years- DesiredKnowledge in ISO-*****, 21CFR***** yearsTroubleshooting techniques (CAPA System, 5 why's, Fish Diagrams, 8 D's) or similar 3 yearsSix 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) 3 years#J-*****-Ljbffr

📌 Ingeniero De Calidad Senior (Mexicali)
🏢 Intuitive Surgical, S. De R. L De C. V.
📍 Mexicali