Quality Engineer

hace 1 semana

Mexicali, México Emprego MX A tiempo completo

**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 processesMonitors manufacturing procedures, processes and records for compliance with established requirementsEvaluates deviations and non-conformances and supports resolution of quality issuesSupports process validation and verificationReviews and trends product and process quality issues using data analysis and root cause investigationResponds to quality escalations and provides technical support for troubleshooting and testingPerform risk analysis and determines quality disposition for variance requests and non-conformancesRepresents the department cross-functionally in meetings that may include senior and external personnelReleases process and document changes through engineering change orders and deviations using ISI change control processEscalates to direct management all quality issues that could impact patient safety or surgical efficacyEnsures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at riskPerforms other duties as assigned by management

**Experiência y requisitos**
- English Level: High Demonstrated interest in medical devices, and the medical fieldBachelor’s degree in Engineering or Life SciencesDemonstrated understanding of medical device QMS requirements and regulatory requeriments, including but not limited to FDACFR 21 820 and ISO 13485Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device environmentExperience with developing and maintaining Standard Operating Procedures and Work InstructionsAbility to be a learn quickly and understand complex products and processesAnalytical, problem-solving and root-cause analysis skillsAbility 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 othersAbility to work independently and handle tasks with competing priorities effectively

**Organización**
- Intuitive Surgical, S. de R.L de C.V.**Correo de contacto**-
- copiar**Giro**
- Maquiladora (Export.)**Actividad principal**
- Productos médicos para cirugía.**Número de empleados**
- 1500**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Turno** Mixto**Jornada** Tiempo Completo**Horario** Monday to friday 7.00 am - 4.30 pm**Estudios** Carrera Profesional**Inglés **Hablado: 90%, Escrito: 90%**Sexo** Indistinto

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