At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Quality Engineer II!
Principal Job Duties and Responsibilities:
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.
Essential Job Duties and 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 CAPA and other programs through complex and 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 CAPA and Quality Plan activities. Communication to senior leaders as needed.
- Manage small projects where appropriate.
- May study, develop and report metrics on projects.
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. 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.
- Experience: Three of 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, 8D etc.) a plus.
Knowledge, Skills and Abilities
- 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
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.