Senior Quality Engineer, Medical Devices – Validation

Intuitive; Mexicali; On-site; MXN 360,000 - 600,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, is seeking a Quality Engineer 3 to join the QA team supporting the da Vinci Surgical System product lines. The role focuses on ensuring safe, reliable products and driving quality improvements across electrical, mechanical, and software subsystems.

The ideal candidate has a Bachelor’s in Engineering or Life Sciences, 1–5 years in medical devices, and experience with CFR 21 CFR 820, ISO 13485, and SAP/ACCS. English proficiency is required.

Qualifications

• English level: High.
• Interest in medical devices and the medical field.
• Bachelor’s degree in Engineering or Life Sciences.
• Knowledge of CFR 21 820 and ISO 13485.
• 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.
• Effective communication, both written and spoken.
• Independent work style with ability to manage competing priorities.

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 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, and communicates constraints to direct management when project completion is at risk.
• Performs other duties as assigned by management.

Skills

English level

Medical devices knowledge

Regulatory knowledge (FDA)

ISO 13485

Engineering change controls

SOPs/Work Instructions

Analytical skills

Communication

Time management

Agile/ACCS

SAP

Auditing

Electromechanical devices

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

SAP

ACCS

Job description

Intuitive, a global leader in robotic-assisted surgery, is seeking a Quality Engineer 3 to join the QA team supporting the da Vinci Surgical System product lines. The role focuses on ensuring safe, reliable products and driving quality improvements across electrical, mechanical, and software subsystems.

The ideal candidate has a Bachelor’s in Engineering or Life Sciences, 1–5 years in medical devices, and experience with CFR 21 CFR 820, ISO 13485, and SAP/ACCS. English proficiency is required.