Myriad Genetics, Inc.

Quality Engineer

US-UT-Salt Lake City
3 weeks ago
Job ID
2017-6683

Overview

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. ***

Responsibilities

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.

Qualifications

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.

About Our Company

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

 

Myriad is an equal opportunity employer and as such, affirms in policy and practice to recruit, hire, train and promote, in all job classifications without regard to race, color, religion, gender, age, sexual orientation, gender identity, national origin, disability status or status as a protected veteran.

 

Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures. We believe that diversity lends a regional, national, and global advantage to the clients we serve. Our workforce consists of dynamic individuals, with a range of backgrounds, talents, and skills.

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