Quality Engineer

Sunrise Systems, Inc.; Salt Lake City (UT); On-site; USD 85,000 - 105,000; Full time

Job summary

A leading medical devices company is seeking a Quality Engineer in Salt Lake City, UT. The role involves leading quality systems development, applying Six Sigma methodologies, and ensuring compliance with medical device regulations. Ideal candidates have a Bachelor's in STEM and 5+ years of relevant experience. Competitive contract role with an emphasis on quality assurance and engineering.

Qualifications

• 5+ years of experience in product development in medical devices.
• Ability to translate customer needs into design inputs and specifications.
• Certified Quality Engineer (CQE) and/or Six Sigma certification.

Responsibilities

• Lead development and improvement of quality systems for R&D.
• Promote the use of statistics in testing and quality control.
• Contribute to maintenance of Design History Files (DHF).

Skills

Design control

Six Sigma methodology

Quality systems development

Medical device regulations

Statistical analysis

Strong PM Skills

Education

Bachelor’s degree in STEM

Master’s degree in STEM

Tools

Quality Engineer certification (CQE)

Six Sigma Green/Black Belt

Job description

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