What are the responsibilities and job description for the Quality Engineering Technician position at Koya Medical, Inc.?
Description
The Position
The Quality Engineering Technician is responsible for performing inspections of returned goods for root-cause analysis and product/process improvement, as well as other QE-related functions, under the direction of the Quality Engineer. Technician documents, tests the function of, inspects, disassembles, and performs measurements on returned electro-mechanical products. Performs a variety of additional tasks in support of quality engineering, involving inspection and analysis of returned product, as well as supporting product refurbishment. Works under general supervision. A certain degree of creativity and latitude is required.
Essential Duties And Responsibilities
The Position
The Quality Engineering Technician is responsible for performing inspections of returned goods for root-cause analysis and product/process improvement, as well as other QE-related functions, under the direction of the Quality Engineer. Technician documents, tests the function of, inspects, disassembles, and performs measurements on returned electro-mechanical products. Performs a variety of additional tasks in support of quality engineering, involving inspection and analysis of returned product, as well as supporting product refurbishment. Works under general supervision. A certain degree of creativity and latitude is required.
Essential Duties And Responsibilities
- Read drawings, wiring diagrams, instructions, inspection and manufacturing documentation to inspect products and components of medical devices.
- Under the direction of Quality Engineer, interpret documented customer complaints to support root-cause analysis
- Under direction of Quality Engineer, test and analyze products returned through the Returned Material Authorization (RMA) system by testing functionality, inspecting and measuring outputs of electronic circuits, disassembling devices to search for flaws, etc.
- Perform inspection of in-process materials and release of assembled medical devices.
- Completing inspection documentation.
- Documenting and notifying supervisor and engineering of product discrepancies.
- Assisting in Nonconformance Report (NCR) creation and follow-up.
- Maintaining inspection and nonconformance records for trending analysis.
- Follow cGMP and ISO requirements.
- Assist in technical functions related to product refurbishment.
- Maintain the inspection work area, documentation, and equipment in a clean and orderly condition and follows prescribed safety regulations.
- 2 years of Quality Inspection or QE/Engineering Technician experience in a medical device or similar regulated environment (e.g. aeronautical), or in the electronics industry
- Understanding of basic electronics, including basic circuit components, soldering, and use of a multimeter
- Excellent verbal communication skills
- Demonstratable knowledge of GMP processes/procedures
- Basic computer skills with MS Office (Outlook, Word, Excel).
- Ability to use precision measuring devices such as calipers, pin gauges, micrometer.
- Manual dexterity and hand- eye coordination needed to inspect medical devices, subassemblies and components.
- Ability to perform unaided and microscopic visual inspection.
- Some lifting to 40 lbs.
- Capability to use equipment such as microscope, mechanical and electrical assembly tooling & fixtures, adhesive dispenser, tweezers, crimpers, cutters and hand tools.
- Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values.
