Quality Engineer 3

Intuitive; Mexicali; Presencial; MXN 360.000 - 540.000; Jornada completa

Descripción de la vacante

Intuitive in Mexicali, Mexico is seeking a Quality Engineer III to join the QA team. You will support manufacturing operations to ensure safety and reliability of the da Vinci Surgical System product lines, including systems, endoscopy and accessories.

You will develop and validate QA procedures, monitor procedures for compliance, perform root-cause analysis, support validation/verification, and manage changes through the ISI change control process.

Formación

• Bachelor’s degree in Engineering or Life Sciences.
• Knowledge of FDA CFR 21 820 and ISO 13485.
• Experience with medical device QMS requirements.
• Analytical, problem-solving, and root-cause analysis skills.
• Ability to communicate effectively, both verbally and in writing.

Responsabilidades

• 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.
• Performs 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.

Conocimientos

Medical devices

QMS knowledge

Root cause analysis

Analytical thinking

English proficiency

Independent work

Educación

Bachelor’s degree in Engineering or Life Sciences

Herramientas

SAP

ACCS

Descripción del empleo

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Global Job Level (HCM): Professional 3 (9)

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

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

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