A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture as a Quality Engineer!
- Perform all work in compliance with the company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System
- Lead the NCR, CAPA, validation and risk management systems to ensure the following:
- Relevant procedures and requirements are considered and applied
- Timely completion of activities
- Lead and guide teams with investigation methodologies and validation strategies
- Document notes, action item recording and follow through, and communication to senior leaders as needed
- Manage large and/or complex projects when assigned
- Work with Engineering to define metrology tools
- Design and implement measurement systems for incoming materials QA inspection team of raw materials used in production
- Read, understand and interpret equipment specifications, test procedures, etc. and be able to write procedures that outline the calibration and maintenance of Measurement & Test Equipment.
- Lead teams with investigation methodologies and provide guidance on validation strategies for measurement systems
- Define, document, and create work instruction procedures and technical reports utilizing GD&T methodologies
- Define, document, and analyze Gauge R&R studies
- Train and mentor incoming materials inspection team on metrology and measurement systems
Training and Education
- Required – Bachelor’s Degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.
- Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required
- Mechanical Engineering degree preferred but not required
- 5+ year of experience in Engineering, Scientific or Investigative role is required.
- Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is required.
- Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) required.
Knowledge, Skills, and Abilities
- Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)
- Technical writing skills
- Ability to collaborate cross-functionally
- Application of Quality Risk Management principles
- Attention to detail (e.g. document reviews, investigation write ups).
- 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.
- Proficiency in MS Office tools, including Outlook, Word, and Excel
- Development of trends and measurement charts
- Advanced project management/leadership skills
- Creating and giving training presentations
- Mentoring peers and leading groups
- SPC methodologies
- Defining, designing, and writing procedures
- Knowledge and experience with parts drawing interpretation and tool application
- Flowcharting of procedures and processes
- Creating and giving training presentations
- Intermediate to professional level technical writing skills
- Advanced Microsoft application skills (i.e Excel, Word, PowerPoint, Visio)
- Statistical software experience, e.g MiniTab, JMP, R Script, preferred
- Effective verbal and written communication skills
- Ability to effectively present information and respond to questions
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Working Conditions and Physical Requirements
- Ability to remain in stationary position, often standing, for prolonged periods.
- Ability to ascend/descend stairs, ladders, ramps, and the like.
- Ability to operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
- Potential for domestic travel for training