Incoming Quality Engineer

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 experiencias 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.

Job Description

The Quality Assurance department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in product and process quality supporting commercial production for all da Vinci™ Surgical System product lines including system platforms, endoscopic instrumentation and supporting accessories.

 The Quality Engineer 3 (QE) 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 QE 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.

Qualifications

• English Level: High.
• 1-5 years relevant experience in a medical device company (preferred).
• Experience with Agile/ACCS and SAP or other electronic documentation systems (Desired).
• Participation in internal /external audits conducted.
• Demonstrated experience on communication with suppliers assessing quality issues and/or validating inspection methods.
• Six sigma and statistical tools (MSA-Measurement System Analysis, Process Capability, SPC-Statistical Process Control)
• Proficient on mechanical drawing interpretation and GD&Ts.
• Experience in Project Management skills.
• Experience in basic and complex tools, measuring equipment.
• 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  requirements, 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 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.
• Work experience with highly complicated electromechanical devices (Desired).

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.