Job Title
Quality Engineer
Location
UTAH
Duration
3-6 MONTHS OF CONTRACT THEN FULL TIME
Position Summary
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.
Essential Duties & 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
Knowledge & Skills
- 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.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university (Engineering or Technology)
- 1-5 years experience
- Prior experience in quality assurance is preferred.
- Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.
Work Environment
- This job operates in a professional office environment and routinely uses standard office equipment
- Work is performed in a safe environment.
- While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled laboratory setting
Utah: Quality Engineer – 2 Spots – Temp to Perm (236201)