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Quality Engineer I

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.


 Job Information  
Business Title: Quality Engineer I   
Department: Quality Assurance  
Cost Center:   
Title of Direct Supervisor: Director of Quality Assurance  
Description of Responsibilities:  
Position Summary: This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of technical aspects of the Quality Management System, including investigations, validations, corrective actions, risk management, and continuous improvement efforts. This person will be working with BioFire employees outside of Quality Assurance on a day to day basis and must have a customer focused attitude.  The person represents Quality Assurance on complex technical and process issues.  They are an advisor to assist resolving problems where they support specialty experts and guide process compliance.  
Primary Duties:  
  • Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
  • May support the NCR, CAPA, Change Control, validation and risk management systems to ensure the following:
    • Relevant procedures and requirements are considered and applied
    • Timely completion of support activities
  • May assist teams with investigation methodologies and validation strategies
  • Assist teams with notes, action item recording and follow through, and communication to senior leaders as needed.
  • Collect change review request for the Change Control Board
  • Prioritize and generate agenda and communication for Change Control Board
  • Assist in facilitation of Change Control Board
  • Ensure change notice and presentation conform to the procedure, review with change owners, prior to Change Control Board
  • May be required to present changes in change control board as requested by change owner
  • Assist in managing Change Control Board meetings, ensuring regular review and adjustment of representatives
  • Support teams and coordinate with other Change Control Quality Engineers to ensure change control requirements are documented in detail to meet compliance requirements
  • Open and complete Change Records in the Trackwise Digital Tool
  • Assist in maintain change control log, ensuring system risks are documented in both the change notice and change log
  • Train site employees on Change Control process
  • Provide backroom audit support
  • Work closely with risk management documentation to ensure proper change assessments
  • Support gap assessments as needed for changing corporate and regulatory guidance.

Supplemental Data - NA  


Training & Education:   

  • Required – Bachelor’s Degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.
  • Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.

Will work experience be accepted in lieu of a degree? Yes  

If yes, number of years of experience accepted in lieu of degree and type: 10 years  


  • Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below
  • Previous experience in an Engineering, Scientific or Investigative role is preferred.
  • Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.
  • Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) a plus.

Knowledge, Skills, and Abilities  

  • Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)
  • Technical writing skills
  • Writing procedures, flowcharting
  • Ability to collaborate cross-functionally
  • Application of Quality Risk Management principles
  • Attention to detail (e.g. document reviews, investigation write ups).
  • High level of written and verbal communications skills
  • Ability to communicate with Statisticians and perform statistical calculations as instructed. 
  • Wisdom to seek help when needed.
  • Proficiency in MS Office tools, including Outlook, Word, and Excel

Working Conditions and Physical Requirements: Ability to remain in stationary position, often standing or sitting, for prolonged periods.  

Domestic Travel - up to 5% of time   

Supervisory Responsibilities: None  


Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e.,,, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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