Quality Engineering Technician
About the role
Koya is always looking for curious and passionate individuals who want to join a fast-paced team for a career in transforming venous and lymphatic care through innovative people-centric technologies that improve lives and empower self-care. Koya values integrity, humility, hard-work, camaraderie, and fun.
Responsibilities
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.
- Read drawings, wiring diagrams, instructions, inspection and manufacturing documentation to inspect products and components of medical devices.
- Interpret documented customer complaints to support root-cause analysis under the direction of the 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.
- Complete inspection documentation and document and notify supervisor and engineering of product discrepancies.
- Assist in Nonconformance Report (NCR) creation and follow-up.
- Maintain 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 follow prescribed safety regulations.
Qualifications
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 or automotive industries.
Skills
- Understanding of simple mechanical systems and materials
- Basic electrical knowledge, including use of a multimeter
- Excellent verbal communication skills
- Demonstrable 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
Pay
The pay range for this role is $80,000 - $80,000 USD per year (Dallas).
Schedule
This position is full-time and will work in our Dallas, TX location.