Quality Engineer

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 2 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 Quality engineer 2 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:

• Analysis, trending, and presentation of factory quality data.
• Identification of emergent or persistent product failure modes or process quality issues through data analysis and root-cause investigation; assisting cross-functional teams with implementation of fixes.
• Monitors manufacturing procedures, processes, and records for compliance with established requirements.
• Reviews and trends product and process quality issues using data analysis and root cause investigation.
• Perform risk analysis and participate in determine quality disposition for variance requests and non-conformances

• Roles & Responsibilities:

   

• Analysis, trending, and presentation of factory quality data.
• Identification of emergent or persistent product failure modes or process quality issues through data analysis and root-cause investigation; assisting cross-functional teams with implementation of fixes.
• Monitors manufacturing procedures, processes, and records for compliance with established requirements.
• Reviews and trends product and process quality issues using data analysis and root cause investigation.
• Perform risk analysis and participate in determine quality disposition for variance requests and non-conformances. 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 
• Participates in successful completion of department projects, communicates constraints to direct management when successful project completion is at risk
• Performs other duties as assigned by management
• Escalates to direct management all quality issues that could impact patient safety or surgical efficacy 
• Participates in successful completion of department projects, communicates constraints to direct management when successful project completion is at risk
• Performs other duties as assigned by management

Skills, Experience, Education, & Training:

• English Level: High (80%).
• Demonstrated interest in medical devices, and the medical field
• Bachelor’s degree in Engineering or Life Sciences.
• Minimum of  2 - 4 years of related work experience;  
• Has previous experience in understanding of medical device QMS requirements and regulatory requirements, including but not limited to FDA CFR 21 820 and ISO 13485 (Desirable).
• Has previous experience in understanding of engineering change controls, process verification and validation, and production and process controls in a medical device environment or experience in an industry controlled by other regulations (Automotive, Aerospace) (Desirable).
• Demonstrated understanding of and ability to perform the Quality Control Engineering function at ISI, while executing routine work with little to no supervision, working on with minimal instruction, identifying issues independently, and proposing viable solutions.
• Experience with developing and maintaining Standard Operating Procedures and Work Instructions
• Ability to be a “Quick Learner” 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 other’s values in decisions, communications, actions, and when dealing with others.

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.