Quality Engineer I

Position Summary: 

This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of BioFire Quality Assurance technical systems and continuous improvement programs.

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.

Primary Duties:

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Supports the NCR, CAPA and other programs to ensure the following: Appropriate process and compliance issues are followed and that 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. Performs other duties as assigned.

Training, Education & Experience:

1. Required – Bachelor’s Degree in a related field.
2. ASQ Certified Quality Engineer and/or Certified Six Sigma Green Belt a plus.
3. Experience with Quality Management Systems that are compliant to FDA – CFR, ISO 13485, ISO 9000, and CMDR at a minimum.
4. Application and use of Continuous Improvement and QA tools—(Pareto, flow charts, Ishikawa, process capability, histogram, etc.) a plus.

Knowledge, Skills & Abilities:

1. Development of Trends and Measures
2. Writing procedures, flowcharting
3. Creating and giving training presentations.
4. Attention to detail.
5. High level of written and verbal communications skills
6. Ability to communicate with Statisticians and perform statistical calculations as instructed.  Wisdom to seek help when needed.

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. Hotmail.com, Gmail.com, Yahoo.com, 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 https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

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 recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).