Postmarket Surveillance Specialist I - job 2 of 2

Description

BioMerieux is seeking a detail-oriented and collaborative individual to join us as a Postmarket Surveillance Specialist I (PSSI). The Postmarket group monitors product performance throughout its life cycle according to US and international regulations for medical devices. In this role, you will provide essential support to our Postmarket team to investigate escalated complaints, monitor for trends, and ensure internal and external regulatory compliance.

The PSSI position requires excellent verbal and written communication skills and a demonstrated organizational competence. Being adaptable to manage competing priorities, and the ability to think critically and problem solve will be essential to your success. Proficiency in MS Office Suite and basic business technologies like email and video conferencing are expected.

No prior experience is required for this position, but directly related lab experience is preferred. The ideal candidate will hold a B.S. in a scientific field or will have an Associate’s degree and have exceptional lab experience. The physical requirements are those encountered in a general office setting.

Essential Job Duties and Responsibilities

• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System
• Review and assess escalated customer complaints and provide recommendations accordingly
• Conduct initial investigations on escalated complaints as part of the complaint investigation process
• Consult with senior members and leadership to determine if a malfunction has occurred by assessing evidence gathered from the customer, manufacturing records, associated complaints, and product labeling
• Provide support to higher risk investigations by conducting data verification, ensuring all data and information is correct and complete
• Provide administrative support and help with organizing, attending, and participating with functional group meetings
• Perform other duties as assigned