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. We offer a base + bonus compensation package, and a competitive benefits program.

Job Summary

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. This position will report to the Quality Engineer in the quality department. The role is full time and will work in our Dallas, TX location.

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

● 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 follow prescribed safety regulations.

Minimum Qualifications

Education, Experience and Training

● 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

Knowledge, Skills and Abilities

● 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

Core Competencies

Continuous Improvement, Problem Solving, Service Focus, Collaboration & Team, Communication, Change Agility, Mission & Vision Focus, Stewardship

Supervisory Responsibilities (as applicable)

Setting targets for performance in ways that align with Koya’s corporate goals and vision. Organizing workflow and ensuring that employees understand their work and

priorities. Monitoring employee productivity and providing constructive feedback and coaching. Hiring, training and developing team members. Assessing employee performance and achievement of goals. Leading, motivating and empowering staff.

Tools and Technology

G Suite, Microsoft Office Suite, Adobe, Salesforce CRM, etc.

Physical Functions and Work Environment

The physical functions described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers; handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties

requested by any Koya manager authorized to provide instruction or assign work. Duties, responsibilities, and activities may change at any time with or without notice. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

Koya Medical, Inc. is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.