Quality Operations Engineer (Mexicali)

Primary Function of Position

The Quality Operations Engineer works independently to drive the continuous improvement of all Quality Operations processes while meeting customer demands, area metrics and maintaining a high level of output quality. The Engineer will support engineering needs across the areas of IQC- Incoming Quality Control, PMC- Preventive Maintenance & Calibration, MRB - Material Review Board, DHR - Device History Record.

Roles & Responsibilities

• Creates, analyzes and manages closure of Equipment Events (EEs)
• Creates and approves engineering changes
• Designs tools, as needed, to support PMC activities
• Participates in special projects related to PMC execution and cost efficiency, including RFID, in-house verification, and rebuild processes.
• PM and calibrate ISI Systems as 3000,4000, SP, ION or other required by ISI
• Perform/install system upgrades as necessary.
• Provide technical and clinical support to end-users and other ISI employees.
• Perform maintenance inspections as required to ensure system meets performance specifications.
• Maintain accurate configurations of installed base.
• Manage spare parts inventory.
• Creates procedures for in-house calibration activities
• Performs assessment, diagnosis and supports troubleshooting of ISI equipment not performing per equipment specifications.
• Derives tolerance specifications from engineering CAD models and Engineering specifications for inspection, maintenance and troubleshooting activities.
• Work with incoming quality inspection team to develop and revise inspection plans.
• Support other quality operations initiatives as directed by the manager.

Qualifications

• BS in Mechanical, Electrical Engineering or equivalent
• Familiar with Six Sigma principles/tools
• English 80% or higher
• Trained on ISI systems 3000, 4000, SP, ION or other required by ISI, desirable
• Capable of performing data analytics, excel/VBA, Tableau
• Able to work independently, switch gears and wear multiple hats
• Experience troubleshooting and resolving anomalies in Equipment, Fixtures, and Tooling, including the use of calipers, DMMs, and pin gauges
• Proficiency in Solidworks
• Honest, thorough, and self-motivated
• Understanding of Inspection (GD&T), Metrology, PMC, and GMP
• Comfortable with all phases of the product development process, including prototype assembly, test, debug, transfer, and sustaining
• Excellent creative problem-solving skills
• Excellent communication and documentation skills
• Comfortable troubleshooting and resolving complex assemblies