This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of technical aspects of the Quality Management System, including investigations, validations, corrective actions, risk management, and continuous improvement efforts. This person will be working with BioFire employees outside of Quality Assurance on a day to day basis and must have a customer focused attitude. The person represents Quality Assurance on complex technical and process issues. They are an advisor to assist resolving problems where they support specialty experts and guide process compliance.

• Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.

• May support the NCR, CAPA, validation and risk management systems to ensure the following:

• Relevant procedures and requirements are considered and applied

• Timely completion of support activities

• May 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.

• Other Duties

• Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)

• Technical writing skills

• Writing procedures, flowcharting

• 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

• Work with Engineering to define metrology tools.

• Work with engineering to design and implement measurement systems for raw materials and in-process assemblies.

• Qualify and Validate new measurement equipment.

• Create and develop new test methods.

• Create and develop fixturing to facilitate efficient measurement processes.

• Qualify and Validate Test Methods.

• Publish and coordinate TM Protocols and Reports.

• Initiate and document technical reviews with supporting teams to establish possible changes to improve upon a procedure or component. This may include improved test methodologies, drawing changes, process changes and others.

  Training & Education :

• Bachelor’s Degree in a Metrology-related discipline is desired. Minimum 2 years professional experience in Metrology role is required.

• Formal training in CMM Programming language(s) is required (i.e. PC-DMIS, Calypso, MeasureMind, etc.)

• Training and/or coursework in Geometric Dimensioning and Tolerancing (GD&T) is required.

• Understanding of Risk Management for Medical Device, ISO 14971 is desired.

  Experience:

• 2+ year of experience in Coordinate Measuring Machine (CMM) programming is required.

• Experience in remote programming of measurement routines is desired.

• Practical application of Validation methodologies, including Test Method Validation is required.

  Knowledge, Skills, and Abilities

• Advanced setup and measurement of complex geometries.

• Proven programming skills.

• Adapting Model Files to Measurement Routines on contact (CMM’s) and optical (VMM’s.)

• Performing Gage Repeatability and Reproducibility (GR&R) studies.

• Fixture design and creation utilizing Solidworks or other modeling software.

• Training Technician and Specialist-level positions.

• Validation Protocol creation.

• Validation execution.

  Validation Report generation

  Solidworks training a plus