Summary:
This position will need to learn, understand, and follow the written processes necessary for Infusion Pump Service operations, including repair, rework, refurbishment, out of box failures analysis, and complaint investigations. They will need to learn key aspects of the Service process, including PCI (Product Complaint Investigation) analysis and device history investigation.
Also responsible for documenting the required aspects of Infusion Pump PCI, repair, refurbishment, rework, and labor and material tracking jobs. This person must be able to operate 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 work related to the repair, rework or refurbishment of medical devices.
Troubleshoot and analyze customer device returns to problem solve root cause issues, working with Senior or Lead Technicians or the Supervisor or Manager as needed.
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) and company’s QMS.
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.
Work with Manager and QA to identify and resolve process and/or product non-conformities.
Clean the assigned work area on daily basis to maintain clean work environment.
Work on special projects as they arise.
Qualifications:
High School diploma or GED equivalent.
A.S. degree in a technical discipline preferred, or equivalent experience.
Minimum of 2 years of industry experience in a high-tech manufacturing or servicing environment.
Demonstrate initiative and good teamwork skills.
Experience with cGMP, process, and product knowledge a plus.
Verbal and written communication skills.
Ability to read, understand, and follow complex written procedures.
Quality and results-oriented.
Travel Requirements:
Typically requires travel less than 25% of the time
Work Environment:
Job duties are performed in a service repair hub environment.
Must have a high level of hand-eye coordination and manual dexterity to work with electro-mechanical medical devices.
Must be able to lift 25 lbs.
Job Type: Contract
Pay: $25.00 - $27.00 per hour
Expected hours: 40 per week
Work Location: On the road