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Quality Engineer II

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

bioMerieux logo

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

Responsibilities:

  • Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
  • Perform duties of a Quality Engineer I without direct supervision.
  • Lead NCR, CAPA and other programs through non-complex projects to ensure the following:
    • Appropriate process and compliance issues are followed
    • Teams maintain prompt progress towards closure
  • Lead teams with investigation methodologies and provide guidance on validation strategies
  • Document NCR, CAPA and Quality Plan activities.  Communication to senior leaders as needed.
  • Manage small projects where appropriate.
  • May study, develop and report metrics on projects
  • 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.

 

Studies and Experience:

  • 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.
  • Three of more years of experience in an Engineering, Scientific or Investigative role is required
  • Experience 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, 8D etc.) a plus.

 

Skills and Qualifications:

  • Experienced in conducting problem investigations
  • Development of Trends and Measures
  • Writing procedures, flowcharting
  • Ability to collaborate cross-functionally
  • Application of Quality Risk Management principles
  • Project leadership skills
  • Creating and giving training presentations.
  • Attention to detail (e.g. document reviews, investigation write ups).
  • Intermediate level technical writing skills
  • Ability to identify and calculate appropriate statistical methods for non-complex problems.  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

 

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.

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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