Quality Engineer I - Complaints (hybrid)

ICU Medical•Salt Lake City, UT

4d•Hybrid

About The Position

The Engineer I, Quality – Complaints will methodically process and investigate Medical Device customer feedback (complaints) in a high-paced, efficient, and accurate manner. This role involves completing basic projects assigned by more experienced engineers and managers, working on matters of limited complexity in a support role under close supervision. The position requires a willingness and capability to work with used, and therefore contaminated, Medical Devices in a controlled setting, and to communicate information effectively both internally and externally in a professional manner.

Requirements

Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM).
0-2 years experience.
Knowledge of Microsoft Word, Excel, and Outlook.
Has engineering foundation. Expected to spend majority of time learning best practices.
Has a basic understanding of engineering discipline.
Willingness to learn/understand the big picture.
Ability to complete projects with minimum supervision.
Requires the ability to provide input and recommendations that impact the completion of project goals.
Must be at least 18 years of age.

Nice To Haves

Prior experience in quality assurance is preferred.
Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.

Responsibilities

Methodically process and investigate Medical Device customer feedback (complaints) in a high-paced, efficient, and accurate manner.
Identify critical dimensions on component drawings and submit dimensional inspection requests.
Carry out basic standardized test methods and/or submit functional testing requests.
Establish and maintain communication both internal and external (with customers and regulatory personnel as needed).
Perform domestic and international regulatory vigilance reporting.
Write effective reports in a timely, priority-driven manner, working effectively in a team environment with shifting priorities and time-sensitive requirements.
Reference existing work to complete similar projects and improve on previous work.
Provide input to product teams regarding the development of new designs, methods, or processes.
Work under the supervision of more experienced engineers.
Complete regular assignments with minimum supervision.
May assist in training new employees with respect to documentation, use of equipment, laboratory techniques, and department procedures.
Deliver communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize utility and promote cross-functional collaboration.
Work on special projects as they arise.