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Quality Engineer I

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.

Description

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 systems.  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.

PLEASE NOTE:  The working schedule for this position is Wednesday - Saturday from 8:00 AM - 6:30 PM.

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. Supports the NCR, CAPA and other programs to ensure the following:
    1. Appropriate process and compliance issues are followed
    2. Teams maintain prompt progress towards closure
  3. Assist teams with investigation methodologies and validation strategies
  4. Assist teams with notes, action item recording and follow through, and communication to senior leaders as needed.
  5. Study and report metrics on projects
  6. Other Duties – see relevant Appendix section if applicable

Supplemental Data:

This is mid-level position with room for growth and additional responsibility as skills are demonstrated.

Training and Education: 

  1. Required – Bachelor’s Degree in a related field.

Experience:

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

Skills: 

  1. Development of Trends and Measures
  2. Writing procedures, flowcharting
  3. Ability to collaborate cross-functionally
  4. Application of Quality Risk Management principles
  5. Creating and giving training presentations.
  6. Attention to detail.
  7. High level of written and verbal communications skills
  8. Ability to communicate with Statisticians and perform statistical calculations as instructed. Wisdom to seek help when needed.

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. Must be able to perform duties while wearing a PAPR.

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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