Quality Engineer I - Complaints (hybrid)

ICU Medical•Salt Lake City, UT

5d•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. The Engineer I will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed.

Requirements

A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting
Take in and communicate information effectively
Communicate externally as needed, and do so in a professional manner
Knowledge of Microsoft Word, Excel, and Outlook
Has engineering foundation.
Expected to spend majority of time learning and best practices.
Has a basic understanding engineering discipline.
Willingness to learn/understand 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
Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM)
0-2 years experience

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 the customers and regulatory personnel as needed)
Domestic and International Regulatory vigilance reporting is essential
Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
References existing work to complete similar projects. Improves on previous work.
Provides input to the product teams regarding the development of new designs, methods or processes.
Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision.
May assist in training new employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
Work on special projects as they arise