Senior Quality Engineer, Medical Devices (Onsite)

Intuitive; Mexicali; On-site; MXN 360,000 - 540,000; Full time

Job summary

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.

Qualifications

• 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.

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.
• 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.

Skills

Medical devices

QMS knowledge

Root cause analysis

Analytical thinking

English proficiency

Independent work

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

SAP

ACCS

Job description

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.