Intuitive Surgical, S. de R.L de C.V.

Quality Engineer

Intuitive Surgical, S. de R.L de C.V.

Mexicali, Baja California

Hace 10 horas

Giro

Maquiladora (Export.)

Actividad principal

Productos médicos para cirugía.

Número de empleados

1500

Sitio Web corporativo

Datos de sucursal

Calzada Venustiano Carranza 1745 Sin Asignacion Mexicali, Baja California

Descripción y detalle de las actividades

The Quality Control Engineer (QCE) works with a team of dedicated individuals supporting manufacturing operations to assure quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The QCE evaluates product quality issues, performs root cause analysis, identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure. Roles & Responsibilities: Develops and validates quality assurance procedures, sampling plans, methods, equipment and processes Monitors manufacturing procedures, processes and records for compliance with established requirements Evaluates deviations and non-conformances and supports resolution of quality issues Supports process validation and verification Reviews and trends product and process quality issues using data analysis and root cause investigation Responds to quality escalations and provides technical support for troubleshooting and testing Perform risk analysis and determines quality disposition for variance requests and non-conformances Represents the department cross-functionally in meetings that may include senior and external personnel Releases process and document changes through engineering change orders and deviations using ISI change control process Escalates to direct management all quality issues that could impact patient safety or surgical efficacy Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk Performs other duties as assigned by management https://careers.intuitive.com/i/us/en/createprofile?imRurl=https://careers.intuitive.com/i/us/en/job/JOB1868/Quality-Engineer

Experiencia y requisitos

English Level: High Demonstrated interest in medical devices, and the medical field Bachelor’s degree in Engineering or Life Sciences Demonstrated understanding of medical device QMS requirements and regulatory requeriments, including but not limited to FDA CFR 21 820 and ISO 13485 Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device environment Experience with developing and maintaining Standard Operating Procedures and Work Instructions Ability to be a learn quickly and understand complex products and processes Analytical, problem-solving and root-cause analysis skills Ability to communicate effectively both verbally and in writing Integrity: Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when Dealing with others Ability to work independently and handle tasks with competing priorities effectively

Número de vacantes 1

Área Calidad

Contrato Permanente

Turno Diurno

Jornada Tiempo Completo

Horario Monday to friday 7.00 am - 4.30 pm

Estudios Carrera Profesional

Inglés Hablado: 90%, Escrito: 90%

Sexo Indistinto