The company is looking to solve the problem of efficiently inspecting and testing complex medical instrumentation, documenting findings, and processing returned instruments and accessories in a timely manner.
Requirements
- Proficient in use of personal computers as part of daily work, including knowledge of the Microsoft Office suite and SAP ERP System, ACCS (Agile) system (our quality system) to retrieve and submit on-line documentation.
- Ability to read and understand diagrams, schematics, assembly drawings, fab drawings, mechanical component drawings.
- Regular use of diagnostic software for localizing equipment and system problems, specialized testing equipment, analyzers, digital oscilloscopes, digital multimeters, clocks, timers, calipers, voltmeters, power supplies, rulers, and other test equipment as required.
- Ability to do basic math.
- Ability to apply logical, sensible understanding to carry out instructions.
- Ability to suggest and implement process improvements.
- Knowledge of DOP’s, SOP’s and MPI’s pertaining to I/A RMA operations.
Responsibilities
- Perform failure analysis of defective instruments and accessories by evaluating the mechanical, electrical, and physical characteristics of returned items.
- Perform Disposition of Excess and System Trade in RMA I&A returns
- Documenting failure analysis findings in clear and concise way in QMS system
- Assist Advance FA team on regulatory requirements in resolving “Reportable I/A” events and “Recalled” instruments.
- Regular communication with failure analysis engineering group and post market surveillance
- Able to perform Failure analysis of Core instrumentation and accessories.
- Sets up and operates machines/equipment /fixtures needed to perform inspection and testing processes.
Other
- Minimum High school diploma and AA or equivalent Minimum of AA or college degree preferred; 2-4 years related experience or training; or equivalent combination of education and experience.
- Ability to read, write and understand English.
- Ability to communicate effectively with technical and non-technical internal customers.
- Acute attention to detail; excellent organizational skills.
- High level of professional integrity and ethics
