Technician I, Environmental Quality

Job Title

Repair Technician II

FLSA Status

Non Exempt

Work Arrangement

Onsite

Job Title

Repair Technician II

FLSA Status

Non-Exempt

Position Summary

This position will need to understand and demonstrate the ability to perform activities necessary for Infusion Pump Service operations, including repair, refurbishment, out of box failures analysis and complaint investigations. In addition, this position may be responsible for training new employees on key aspects of the Service process, including PCI (Product Complaint Investigation) analysis, device history investigation, and true root cause analysis to component level if required.

Also responsible for documenting the required aspects of Infusion Pump PCI, repair, refurbishment, rework, and labor and material tracking jobs. This person must be proficient with the device tracking system (Oracle) so that the complaints are addressed, and all results are technically accurate and include required elements ensuring that the analysis / repair activity is properly recorded.

Essential Duties & Responsibilities

• Will perform routine and complex work related to the repair, rework, refurbishment or upgrades of medical devices.
• Troubleshoot and analyze customer device returns to problem solve root cause issues.
• Comply with all the requirements in the Quality and Operational procedures in their area of responsibility to meet the requirements of all applicable Quality System Regulations (i.e. cGMP compliance).
• Perform Level 0 and Level 1 PCI investigations on a regular basis, working as necessary with Senior Technicians, QA, Customer Service and Global Complaint Management teams as necessary.
• Assist with notebook / engineering studies, out of box failures analysis and yield improvement activity.
• May perform troubleshooting and repair of devices onsite at customer locations.
• Work with Manager and QA to identify and resolve process and / or product non-conformities.
• Assist Senior Technicians or Engineering with On-the-Job training activities as required.
• Clean the assigned work area on daily basis to maintain clean work environment.
• Work on special projects as they arise.

Knowledge, Skills & Qualifications

Education and Experience

Minimum Qualifications

Travel Requirements

Physical Requirements and Work Environment