This position will review, investigate, triage and recommend escalated compliant investigations for closure. As needed, the Postmarket Surveillance Specialist II (PSS-II) will coordinate investigations with departmental teams to identify complaint cause. The complaint investigation reports are routinely reviewed by external auditors and writing, knowledge of the subject matter and attention to detail are expected. As guided by work instruction documents, the PSS will review the complaint investigations for medical device reporting and work with senior complaint investigation staff to assess any potential impact to the patient care.
- 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 BioFire product 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.
Studies and Experience:
- Bachelor’s degree in Scientific Field.
- Minimum 3 years troubleshooting of molecular or microbiological diagnostic test or clinical lab experience is preferable.
Skills and Qualifications:
- Investigational Report Generation
- Analytical Skills
- Time Management
- Ability to work independently
- Ability to follow detailed processes
- Knowledge of medical device regulation preferred