Job Description

Description

• PCI / Troubleshooting/Analysis experience working with QA Technicians

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

• Demonstrate initiative and good teamwork skills
• Proficient with cGMP, process, and product knowledge
• Good verbal and written communication skills
• Ability to edit written process documentation as necessary
• Proven analytical thinking and problem-solving skills
• Quality and results oriented

Education and Experience

• High School diploma or GED equivalent
• A.S. degree in a technical discipline preferred, or equivalent experience
• 1-3 yrs of industry experience in a high-tech manufacturing, service repair or related environment.

Job Type: Full-time

Pay: $22.00 - $26.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Infusion Pump Service: 1 year (Preferred)
• Troubleshooting: 1 year (Preferred)

Work Location: In person

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