• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System.
• Review, assess escalated customer complaints and distribute accordingly.
• Conduct moderately complex risk investigations on escalated FilmArray complaints as part of the complaint investigation process. Investigations may include control failures, erroneous results, known issues, etc.
• Assess Complaint Investigation for CAPA.
• Consult with senior members and leadership to determine if a malfunction has occurred by assessing run files, evidence gathered from the customer, manufacturing records, associated complaints, and product labeling
• Provides support to higher risk investigations by conducting data verification, ensuring all data and information is correct and complete.
• Determine probable cause by assessing run files, evidence gathered from the customer, manufacturing records and associated complaints.
• Work with customer support to advise an RMA, product replacement or appropriate re-training.
• Investigate potential for malfunction impact on patient care.
• Triage additional investigation to departments when needed.
• Report timeliness of complaint investigation turn around.
• May provide administrative support and help with organizing, attending, and participating with functional group meetings.
• Assign the appropriate risk to the Complaint Investigation tickets.
• Performs other duties as assigned.

Qualifications

• Bachelor's degree in Scientific Field.
• Minimum 3 years troubleshooting of molecular or microbiological diagnostic test or clinical lab experience is preferable.
• Investigational Report Generation
• Communication
• Writing
• Analytical Skills
• Time Management
• Ability to work independently
• Ability to follow detailed processes
• Knowledge of medical device regulation preferred