What are the responsibilities and job description for the Postmarket Surveillance Specialist II position at bioMérieux?
Description of Responsibilities
Position Summary
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.
Primary Duties
- Reviews and assesses escalated customer complaints.
- Conducts moderately complex risk investigations on escalated BIOFIRE complaints as part of the complaint investigation process. Investigations may include control failures, erroneous results, known issues, etc.
- Assesses complaint investigations for CAPA.
- Consults 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.
- Determines probable cause by assessing run files, evidence fathered from the customer, manufacturing records, and associated complaints.
- Works with customer support to advise on RMA, product replacement, or appropriate re-training.
- Investigates potential for malfunction impact on patient care.
- Triages additional investigation to other departments when needed.
- Completes Complaint Investigations in a timeline manner.
- May provide administrative support and helps with organizing, attending, and participating with functional group meetings.
- Assigns the appropriate risk to Complaint Investigation tickets.
- Performs all work in compliance with company quality procedures and standards.
- Performs other duties as assigned.
Qualifications
Training and Education
Bachelor’s degree in a scientific field.
Experience
Minimum 3 years troubleshooting of molecular or microbiological diagnostic test or clinical lab experience is preferable.
Knowledge, Skills, and Abilities
- Investigational Report Generation
- Communication
- Writing
- Analytical Skills
- Time Management
- Ability to work independently
- Ability to follow detailed processes
- Knowledge of medical device regulation preferred
