Quality Engineer 3

Job Description

Primary Function of Position: 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

Skills, Experience, Education, & Training:

• 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 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.

• 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 (preferred).

• 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.

• 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.

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