Quality Engineer
Job in
Salt Lake City, Salt Lake County, Utah, 84193, USA
Listed on 2025-12-01
Listing for:
Sunrise Systems, Inc.
Contract
position Listed on 2025-12-01
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Manufacturing Engineer, Process Engineer
Job Description & How to Apply Below
Delivery Manager - Recruitment at Sunrise Systems, Inc. Our client, a leading medical devices manufacturing company, is looking for a Quality Engineer
. This is for an initial duration of 9 months and is located in Salt Lake City, UT
.
Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)
Duties and responsibilities- Leads or assists in the development of, and continuous improvement of, quality systems for R&D in compliance with 21 CFR 820, ISO 13485 and EN requirements with specific focus on design control.
- Leads Risk Management plans/ reports and situational analyses for products under design authorities.
- Promotes the use of statistics in testing and control of quality. Applies Six Sigma methodology to support product development process.
- Contributes to assembly and maintenance the Design History File (DHF)
- Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.
- Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.).
- Advanced knowledge of Six Sigma methodology, statistical methods and analysis.
- Ability to translate customer needs into design inputs and specifications.
- Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Belt
- Strong PM Skills
- At least 5 years’ experience product development in Med devices
- Bachelor’s degree in STEM (Science, Technology, Engineering, Math), and 5 years of engineering experience within the medical device or equivalent regulated industry OR Master’s degree in STEM and 3 years of engineering experience within the medical device or equivalent regulated industry.
- Master’s degree in related engineering discipline.
- Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Belt.
- Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving).
- Mid-Senior level
- Contract
- Quality Assurance, Engineering, and Manufacturing
- Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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