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 Analyst!
The Quality Assurance department provides Quality support across various departments within BioFire. The department is organized into distinct subunits, consisting of Calibration & Preventive Maintenance, Document Control, BioReagents Manufacturing, Instrument Manufacturing, Servicing, Incoming Material QC, QMS Project Management & Auditing.
The Quality Analyst will work under the direction of the Associate Director of QA overseeing QMS Project Management and Auditing, and will be responsible for compiling data across various BFDX Operational Reviews & Annual Post Market Reviews to create an Annual & Quarterly Management Review Summary Report. Additional responsibilities include developing, trending, and monitoring Quality Management System (QMS) Key Performance Indicators (KPI’s) and reporting on the overall health of the QMS.
Principle Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Work with QA Associate Directors to develop meaningful Key Performance Indicators (KPI’s) for the Quality organization
- Collate and assess KPI trends
- Monitor KPI trends to maintain QMS health
- Communicate KPI trends across the organization during Management and Operational reviews
- Must be able to look and analyze trend data, present it in a meaningful and concise manner
- Must be able to recognize problematic trends, and communicate them across the Quality organization
- Summarize written reports to executive leaders within BioFire and Executive leaders of the parent company, BioMérieux
- Work closely with QA Associate Directors to develop Quality Objectives based on department KPI’s
- Track and trend KPI’s over time
- Minimal domestic travel may be required for training purposes
Training and Education
- Bachelor of Science or Master’s Degree (science, engineering or life sciences. Extensive experience in QA field in the Medical Device industry can substitute for a degree.
- Knowledge of good manufacturing practices, ISO 9001, ISO 13485, 21 CFR 820, IVDD/IVDR
- Knowledge of quality principles and regulations applicable to in vitro diagnostic products, including FDA QSR, ISO 13485, CMDR, CE Marking, ISO 9001, ISO 14971, In Vitro Diagnostic Directive/In Vitro Diagnostic Regulation.
- Knowledge of FDA Quality Metrics program a plus
- Minimum 5 years work experience in Medical Device, Pharmaceutical or Biotechnology manufacturing setting that has a formal quality system is required.
- Design, application, trending and analysis of Key Performance Indicators and metrics
- Effective written and verbal communication skills
- Proficiency in MS Office tools, including Outlook, Word, and Excel; experience with MS Visio a plus
- General computer operation
- Proficiency in internet navigation
- Attention to detail is fundamental to this position
- Strong organization is required
- Excellent communication skills, both oral and written
- Technical writing
- Excellent collaboration with cross-departmental leaders within the organization
- Professional communication and peer-to-peer interactions a must
- Critical listening skills
- Ability to prepare clear and concise written summaries for executives and stakeholders
- Must be comfortable presenting, explaining, and documenting data to cross-functional teams including high level Executive Management
- 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.