Quality Operations Engineer
hace 1 semana
**Company Description**: Descripción de la empresa
En Intuitive, estamos unidos detrás de nuestra misión: creemos que la atención mínimamente invasiva es la atención que mejora la vida. Mediante la inventiva y la tecnología inteligente, ampliamos el potencial de los médicos para curar sin limitaciones.
Como pioneros y líderes del mercado en cirugía robótica, nos esforzamos por fomentar un equipo inclusivo y diverso, comprometido con marcar la diferencia. Durante más de 25 años, hemos trabajado con hospitales y equipos de atención de todo el mundo para ayudar a resolver algunos de los desafíos más difíciles de la atención médica y avanzar en lo que es posible.
Intuitive se ha construido gracias a los esfuerzos de grandes personas de diversos orígenes. Creemos que las grandes ideas pueden provenir de cualquier lugar: nos esforzamos por fomentar una cultura inclusiva basada en la diversidad de pensamientos y en el respeto mutuo. Lideramos con inclusión y capacitamos a los miembros de nuestro equipo para que trabajen de la mejor manera y manifiesten su auténtica personalidad.
Las personas apasionadas que quieren marcar la diferencia impulsan nuestra cultura: los miembros de nuestro equipo se basan en la integridad, tienen una sólida capacidad para aprender, la energía para hacer las cosas, y aportan experiências diversas del mundo real para ayudarnos a pensar de nuevas maneras. Invertimos activamente en los miembros de nuestro equipo para apoyar su crecimiento a largo plazo y así poder continuar avanzando en nuestra misión y alcanzar su máximo potencial.
Únase a un equipo comprometido a dar grandes pasos hacia delante para una comunidad global de profesionales de atención médica y sus pacientes. Juntos, avancemos en el mundo de la atención mínimamente invasiva.
Primary Function of Position:
The Quality Operations Engineer works independently to drive the continuous improvement of all Quality Operations processes while meeting customer demands, area metrics and maintaining a high level of output quality. The Engineer will support engineering needs across the areas of IQC- Incoming Quality Control, PMC- Preventive Maintenance & Calibration, MRB - Material Review Board, DHR - Device History Record.
Roles & Responsibilities:
The Quality Operations Engineer may monitor all department metrics and provide recommendations for areas of opportunity or continuous improvement. They may analyze equipment performance, drive fixture development and improvement and assess automation opportunities. The Quality Operations Engineer may update DOPs and write work instructions to clarify or improve department processes. The Quality Operations Engineer also supports engineering activities across all Quality Operations functional areas. Tasks may include the following:
- Creates, analyzes and manages closure of Equipment Events (EEs)
- Creates and approves engineering changes
- Designs tools, as needed, to support PMC activities
- Participate in special projects related to PMC execution and cost efficiency, including RFID, in-house verification, and rebuild processes.
- PM and calibrate ISI Systems as 3000,4000, SP, ION or other required by ISI
- Perform/install system upgrades as necessary.
- Provide technical and clinical support to end-users and other ISI employees.
- Perform maintenance inspections as required to ensure system meets performance specifications.
- Maintain accurate configurations of installed base.
- Manage spare parts inventory.
- Creates procedures for in-house calibration activities
- Performs assessment, diagnosis and supports troubleshooting of ISI equipment not performing per equipment specifications.
- Derives tolerance specifications from engineering CAD models and Engineering specifications for inspection, maintenance and troubleshooting activities.
- Work with incoming quality inspection team to develop and revise inspection plans
- Support other quality operations initiatives as directed by the manager
**Qualifications**:
Skills, Experience, Education, & Training:
- BS in Mechanical, Electrical Engineering or equivalent
- Familiar with Six Sigma principles/ tools
- English 80% or higher
- Trained on ISI systems 3000, 4000, SP, ION or other required by ISI, desirable
- Capable of performing data analytics, excel/VBA, Tableau
- Able to work independently, switch gears and wear multiple hats
- Experience troubleshooting and resolving anomalies in Equipment, Fixtures, and Tooling, including the use of calipers, DMMs, and pin gauges
- Proficiency in Solidworks
- Honest, thorough, and self-motivated
- Understanding of Inspection (GD&T), Metrology, PMC, and GMP
- Comfortable with all phases of the product development process, including prototype assembly, test, debug, transfer, and sustaining
- Excellent creative problem-solving skills
- Excellent communication and documentation skills
- Comfortable troubleshooting and resolving complex assemblies
**Additional Informa
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