Sr. Quality Engineer

Intuitive; Mexicali; On-site; MXN 600,000 - 800,000; Full time

Job summary

Intuitive is seeking a Quality Engineer in Mexicali to ensure compliance with ISO 13485 and 21 CFR820. You will monitor notifications, validate processes, and drive defect reduction across manufacturing lines for medical devices.

The role requires 5+ years in quality engineering within the medical industry, with strong CAPA and auditing experience. Responsibilities include trend analysis, CAPA closure, and cross-functional collaboration with Manufacturing and QA teams.

Qualifications

• Bachelor's degree in engineering required.
• English Advanced required.
• Office software proficiency (Office Suite) required.
• SAP knowledge at intermediate level.
• Minitab knowledge at intermediate level is desirable.
• Quality Engineer or Manufacturing experience in medical devices (≥5 years).
• Experience in process validations (≥5 years).
• Experience in quality audits for medical products (≥3 years).
• Experience in the medical industry (≥3 years).
• Lean Manufacturing experience (≥3 years).
• ISO-13485, 21 CFR820 knowledge (≥3 years).
• Troubleshooting skills (CAPA, 5 Whys, Fishbone, 8D) (≥3 years).
• Six Sigma and statistical tools (DOE, SPC, PFMEA, MSA) (≥3 years).

Responsibilities

• Follow up on quality notifications (VRs, NCRs, etc.) and perform trend analysis.
• Participate in health and safety-related activities when required.
• Use devices, tools, and equipment per process; report defective items.
• Communicate unsafe acts or conditions to supervisors.
• Maintain workstation order and cleanliness (5S).
• Prepare trend reports and CAPA analyses.
• Follow up on quality notifications affecting Mexicali and corporate locations.
• Develop lines, processes, or product validations and document results in SAP/Agile.
• Drive defect reduction projects and mentoring for new quality engineers.
• Complete ISU training and MERIT self-assessments.

Skills

English Advanced

Lean Manufacturing

Six Sigma

Troubleshooting CAPA

ISO-13485 knowledge

Medical quality experience

Education

Bachelor's Degree in Engineering

Tools

SAP

Minitab

Job description

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Onsite, Mexicali, Baja California, Mexico

Job Description

Primary Function of Position:

Ensure 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, 21CFR820); 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

• 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.
• Drives our Culture Strategy by fostering our mission, founding principles, individual and leadership expectations.

Qualifications

• 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

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR 743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones. Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación). Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines. Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable.

Shift

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