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Quality Engineer

Posted on: August 31, 2022
Hr Consultant
  • Full Time
  • De Smet, SD
  • October 15, 2022

Website UltiMed, Inc.

We improve the quality of life for people and pets with diabetes

This highly visible position is a key member of our skilled Quality Team at our De Smet, SD production plant. This role provides leadership for, 1) supplier quality management, 2) product quality management and 3) general quality assurance functions.  The Quality Engineer acts as the point of contact for all quality issues relating to on-site manufacturing as well as supplied components from outside vendors as well as leading all quality and improvement activities and assuring that all quality requirements are in compliance with FDA, ISO, Canadian Medical Device Regulations and other standards.  The Quality Engineer provides quality assurance technical support to operations in order to ensure product quality compliance and safety, and partners with our manufacturing counterparts to drive improvements relating to quality and quality systems. We offer a generous benefits package including medical, dental, vision, life and 401(k) with match. Competitive pay + bonus potential!

REQUIREMENTS:

Bachelor’s degree in mechanical, industrial or manufacturing/process engineering, or another related technical field.
Minimum of 8 years of Quality engineering experience within the medical device or pharmaceutical industry.
Minimum of five (5) years of experience working directly with suppliers.
Experience in customer focused quality and/or process improvement.
Excellent statistical analysis and computer skills (use and understanding of statistical tools).
Excellent Microsoft product skills (Word, Excel, PowerPoint, etc.).
Good written and verbal communication skills.
Highly organized and detail-oriented.
Must be highly skilled leading root cause analysis and problem-solving efforts.
Duties will be performed onsite at the plant with up to 30% travel required; international (primarily Asia) and domestic.
Willingness and ability to travel internationally to drive change while understanding cultural norms.
Experience with plastic injection molding, tooling and molds, automated assembly, UDI barcode printing/scanning, process automation, and Lean Six Sigma manufacturing experience a plus.
Experience in mechanical, industrial or manufacturing engineering is highly desired.
Project Management experience, PMP certification helpful.

Find out more and apply online at https://ultimedinc.hireclick.com/ or send resume to j.tate@ultimedinc.com

For more information, call 651-291-7909 x212

To apply for this job email your details to j.tate@ultimedinc.com