Quality Engineer job Salt Lake City Utah
Quality Engineer job Salt Lake City Utah
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Quality Engineer Job



Employer Name: Myriad Genetics, Inc. SpiderID: 7055811
Location: Salt Lake City, Utah Date Posted: 10/31/2017
Wage: Category: Biotech
Job Code: 100007104

Job Description:

The Quality Engineer is responsible for leading Quality Engineering support during, product design and development, process development, and transfer to manufacturing. Lead and mentor in the development of verification, validation, and study protocols. Lead and mentor risk management and control and reaction plan. Addresses less common and challenging problems with appropriate solutions. Initiates, leads and supports improvement efforts and applies statistical analysis, lean sigma, and other tools and methods to critical business processes driving improvements across functional areas. Provides expert judgment and resolves complex process and quality issues. This role relies on experience and judgment to plan and accomplish goals and the ability to lead cross functional teams, and work in cross-functional teams to attain objectives. Requires excellent writing and communication skills.

*** Must have Current Certified Quality Engineer and/or Six Sigma Black Belt. ***



Job Requirements:

Each employee's specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:



  1. Review new and modified product designs for quality characteristics, including quality, risk management, hazard and risk assessment, product requirements etc.

  2. Responsible for leading and managing quality engineering activities, protocol development data analysis and optimization/improvement activities.

  3. Ensure that new product development and changes to existing products are conducted in compliance with the Myriad Quality Systems, CLIA, ISO, FDA, and other applicable regulations.

  4. Promotes the use of quality engineering tools and methods to process flows, quality improvements, and control and reaction plan, gage R&R, etc.

  5. Create a risk management plan, perform and facilitate product and device hazard analysis, and risk assessment. Assess risks and leads activities of identifying alternatives by utilizing statistical tools and control plans.

  6. Develops measurement systems based on sound quality engineering and lean six sigma principles.

  7. Applies quality engineering tools and principles to product and process validation. Lead and assists in the planning and execution of verification and validation studies.

  8. Ensures sampling, test and validation protocols along with executed validation meet internal specification and regulatory requirements through collaboration with all affected areas.



  1. Coach project teams while applying quality engineering and statistical methods and tools.

  2. Supports the internal quality system and consults in the preparation of technical documents for review and submission to regulatory and accrediting agencies.





Supporting documentation for the education and experience requirements are maintained in the employee's personnel file.



  1. Meets minimum education and experience requirements:

    • Must have current Certified Quality Engineer and/or Six Sigma Black Belt.

    • Minimum of a Bachelor's degree in engineering, science, statistics, or equivalent work experience plus 5+ years of hand on experience.

    • Master's degree in engineering, science, statistics or equivalent work experience plus 3+ years of hand on experience.

    • Knowledgeable in ISO 14971 and 21CFR820.





Desired:


Experience with FDA, and other regulatory requirements in a regulated environment.



The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.

PI100007104



Job Criteria:
Start Date:
Position Type:
Years of Experience Required: 3
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
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Web Site: http://www.Click2apply.net/vh894sxq5tqjnvyb

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