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Quality Engineer III

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality

Description

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Position Summary:

This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of BioFire Quality Assurance technical systems and continuous improvement programs.  Quality Engineer III may lead complex projects addressing programs or quality issues. 

This position will play a key role giving feedback for the design, implementation, and processing of the technical systems, including for example, CAPA, NCR and Quality Plans system.  This person will be working with BioFire employees outside of QA on a day to day basis and must have a customer focused attitude.  The person represents QA on complex technical and process issues.  They are an advisor to assist resolving problems where they support specialty experts and guide process compliance.

Principal Job Duties and Responsibilities:

 

  1. Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
  2. Perform duties of a Quality Engineer II without direct supervision.
  3. Lead NCR, CAPA and other programs through complex projects to ensure the following:
    1. Appropriate process and compliance issues are followed
    2. Teams maintain prompt progress towards closure
  4. Lead and teach teams with investigation methodologies and provide guidance on validation strategies
  5. Document NCR, CAPA and Quality Plan activities. Communication to senior leaders as needed.
  6. Manage large projects where appropriate. Act as specialty expert on multidisciplinary teams.
  7. Study, develop and report metrics on projects

Supplemental Data: 

This is a high-level position, and the employees in this role are expected to deeply understand the company, project management methods and be expert in process analysis, design, and creation.

Training and Education: 

  1. Required – Bachelor’s Degree in a related field. Minimum ten years professional experience in a related field plus ASQ Certification (CQE) or Six Sigma Black Belt may be considered in lieu of a degree.
ASQ Certified Quality Engineer preferred.

Experience: 

  1. Experience: Five or more years in an Engineering, Scientific or Investigative role is required.
  2. Expertise with Quality Management Systems that are compliant to FDA – CFR, ISO 13485, ISO 9000, and CMDR at a minimum.
Application and use of Continuous Improvement and QA tools—(Pareto, flow charts, Ishikawa, process capability, histogram, etc.) a plus.

Skills:  

  1. Proficient in conducting problem investigations
  2. Development and reporting of trends and measures
  3. Designing procedures and processes
  4. Ability to collaborate cross-functionally
  5. Application of Quality Risk Management principles
  6. Advanced project leadership skills
  7. Creating and giving training presentations.
  8. Attention to detail (e.g. document reviews, investigation write ups).
  9. Advanced level technical writing skills
  10. Ability to work with statisticians on complex problems and solve non-complex problems independently. Ability to understand limitation of statistical methods.  Wisdom to seek help when needed.
Proficiency in MS Office tools, including Outlook, Word, and Excel

Physical Requirements: 

Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.


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