Quality Engineer I

Quality Engineer I 

Position

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. 

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 engineering, statistics, mathematics or related field

2. ASQ Certified Quality Engineer and/or Certified Six Sigma Green Belt is preferred.  

Experience 

1. Experience with Quality Management Systems that are compliant to FDA – CFR, ISO 13485, ISO 9000, and CMDR at a minimum.

2. Application and use of Continuous Improvement and QA tools—(Pareto, flow charts, Ishikawa, process capability, histogram, etc.) is preferred. 

Knowledge, Skills, and 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.