Sr. Quality Engineer

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

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.

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

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.