Senior Quality Engineer - Medical Devices & Process Validation

Intuitive Surgical, S. de R.L de C.V.; Mexicali; On-site; MXN 391,000 - 614,000; Full time

Job summary

Intuitive Surgical, S. de R.L de C.V. in Mexicali seeks a Quality Engineer with 5+ years in manufacturing to support process validations, CAPA, and quality audits in a medical products environment. You will lead improvements, analyze defects, and ensure compliance with ISO 13485 and 21 CFR 820.

Role requires English Advanced, SAP and Minitab proficiency, and experience in GMP-like environments. On-site work with a safety-focused team in Mexicali.

Qualifications

• Education: Bachelor\'s Degree in Engineering.
• 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.
• 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

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 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.

Skills

English Advanced

Office Package Advanced

SAP System

Minitab

Lean Manufacturing

Six Sigma

Troubleshooting CAPA

DOE

ISO 13485

21 CFR 820

Quality Engineer or Manufacturing

Education

Bachelor's Degree in Engineering

Tools

SAP System

Minitab

Excel

Job description

Intuitive Surgical, S. de R.L de C.V. in Mexicali seeks a Quality Engineer with 5+ years in manufacturing to support process validations, CAPA, and quality audits in a medical products environment. You will lead improvements, analyze defects, and ensure compliance with ISO 13485 and 21 CFR 820.

Role requires English Advanced, SAP and Minitab proficiency, and experience in GMP-like environments. On-site work with a safety-focused team in Mexicali.