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:
- Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
- Supports the NCR, CAPA and other programs to ensure the following:
- Appropriate process and compliance issues are followed
- Teams maintain prompt progress towards closure
- 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.
- Study and report metrics on projects
- Other Duties – see relevant Appendix section if applicable
This is mid-level position with room for growth and additional responsibility as skills are demonstrated.
Training and Education:
- Required – Bachelor’s Degree in a related field.
- Experience: One or more years 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, etc.).
- Development of Trends and Measures
- Writing procedures, flowcharting
- Ability to collaborate cross-functionally
- Application of Quality Risk Management principles
- Creating and giving training presentations.
- Attention to detail.
- 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.
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.