Roles & Responsibilities:

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- 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 are in 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) curriculum

- Prepares 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.

Qualifications

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- Skills, Experience, Education, & Training:

- Education: Bachelor's Degree Any engineering degree

- English language skills: English Advanced

- System management: Office Package Advanced

- SAP System Intermediate

- Minitab Intermediate - Desired

- Kob or area experience: Quality Engineer or Manufacturing

- Engineer 5 years

- Experience in process validations 5 years

- Experience in quality audits for medical products 3 years

- Have worked in the medical industry 3 years

- Knowledg/skills: Lean Manufacturing 3 years- Desired

- Knowledge in ISO-13485, 21CFR820 3 years

- Troubleshooting techniques (CAPA System, 5 why's, Fish Diagrams, 8 D's) or similar 3 years

- 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) 3 years

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