Quality Engineer I

Description

Position Summary:

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.

Primary Duties:

1. Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
2. May support the NCR, CAPA, Change Control, validation and risk management systems to ensure the following:
   1. Relevant procedures and requirements are considered and applied
   2. Timely completion of support activities
3. May 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. Collect change review request for the Change Control Board
6. Prioritize and generate agenda and communication for Change Control Board
7. Assist in facilitation of Change Control Board
8. Ensure change notice and presentation conform to the procedure, review with change owners, prior to Change Control Board
9. May be required to present changes in change control board as requested by change owner
10. Assist in managing Change Control Board meetings, ensuring regular review and adjustment of representatives
11. Support teams and coordinate with other Change Control Quality Engineers to ensure change control requirements are documented in detail to meet compliance requirements
12. Open and complete Change Records in the Trackwise Digital Tool
13. Assist in maintain change control log, ensuring system risks are documented in both the change notice and change log
14. Train site employees on Change Control process
15. Provide backroom audit support
16. Work closely with risk management documentation to ensure proper change assessments
17. Support gap assessments as needed for changing corporate and regulatory guidance.
18. Develop a close relationship with Design and Development and Manufacturing teams and an understanding of ongoing projects, including liaising with the Project Review Board.

Training, Education & Experience:

1. 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.
2. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
3. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below
4. Previous experience in an Engineering, Scientific or Investigative role is preferred.
5. Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.
6. Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) a plus.

Knowledge, Skills & Abilities:

1. Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)
2. Technical writing skills
3. Writing procedures, flowcharting
4. Ability to collaborate cross-functionally
5. Application of Quality Risk Management principles
6. Attention to detail (e.g. document reviews, investigation write ups).
7. High level of written and verbal communications skills
8. Ability to communicate with Statisticians and perform statistical calculations as instructed.
9. Wisdom to seek help when needed.
10. Proficiency in MS Office tools, including Outlook, Word, and Excel

Physical Requirements:

1. Ability to remain in a stationary position, often standing, for prolonged periods.
2. Domestic travel required for up to 5% of time