Description

• Performs all work in compliance with the company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System
• Perform duties of a Quality Engineer II without direct supervision
• 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
• May study, develop and report Quality related metrics
• Mentorship of lower-level Quality Engineering staff
• Drive efficiency and consistency through continuous improvement in the Change Control process.
• Develop and implement policy and procedures for site Change Control within corporate and regulatory standards. Conduct gap assessments as needed for changing corporate and regulatory guidance.
• Maintain site change control process, ensuring compliance to global procedure and continuously improve the process to support site.
• Participate in TrackWise Digital Change Control process and enhancements
• Maintain process for using TWD tool for change control.
• Coordinate and lead cross-functional meeting with multiple departments to review change assessments and plans (Change Control Board).
• Collect change review request for the Change Control Board.
• Prioritize and generate agenda and communication for Change Control Board.
• Ensure change notice and presentation conform to the procedure, review with change owners, prior to Change Control Board.
• Assess and approve change notifications to evaluate if proposal satisfies company standards. Ensure change proposals have comprehensive rationale, impact assessment, implementation plans and follow up actions documented. Ensure all approved actions are implemented as per commitment.
• Provide advice and mentorship to cross-functional teams to enable successful and compliant change controls. Support teams in conducting impact assessments for the change.
• Work closely with risk management documentation to ensure proper change assessments.
• Approve the Change Record in the Trackwise Digital Tool
• Close the Change Record in the Trackwise Digital tool with the Change Summary has been completed and approved.
• Present business critical and regulatory impactful change controls and metrics to senior leadership.
• Use TrackWise digital reports and dashboards to monitor change records
• Develop, implement, and monitor metrics for site change control and report regularly to leadership
• Maintain change control log, ensuring system risks are documented in both the change notice and change log
• Prepare annual change control log for review and approval
• Analyze and document cumulative change review quarterly with molecular and data science teams
• Train site employees on change control process.
• Fulfill role as audit subject matter expert for change management during audits.
• Support internal and external audits and compliance assessments.
• Maintain a close relationship with Design and Development and Manufacturing teams and an understanding of ongoing projects, including liaising with the Project Review Board.

• 5+ year of experience in an 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.
• Experience guiding and/or mentoring team is preferred.

1. Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)
2. Technical writing skills
3. Designing and 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
11. Developing and reporting Trends and Measures
12. Advanced Project management/leadership skills
13. Creating and giving training presentations
14. Mentoring peers and leading groups