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Sunrise Systems, Inc.

Quality Engineer

Sunrise Systems, Inc., Salt Lake City, Utah, United States, 84193

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Overview

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 Education

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. Desired / Additional Skills & Knowledge

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). Seniority level

Mid-Senior level Employment type

Contract Job function

Quality Assurance, Engineering, and Manufacturing Industries

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing

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