Field Assurance Specialist; Bachelors

Position

Field Assurance Specialist

Covington, GA

The Field Assurance Specialist will coordinate the review, investigation, and corrective actions associated with product complaints with the responsible manufacturing facilities in accordance with Corporate and Divisional policies and procedures, Quality System Regulations, and other regulatory requirements.

• Bachelor degree required
• Receive complaints and follow up to collect relevant information from the user.
• Decision making skills for complaint determination.
• Responsible for accurate complaint entry for disposable medical devices and capital equipment for both domestic and international customers.
• Follow up with customers and sales representatives to obtain additional information when necessary and to request return of overdue complaint samples.
• Arrange for the return of complaint samples.
• Match any returned samples with their corresponding complaint files and perform preliminary evaluations on returned samples to verify they are correct per the documented file.
• Review and approve investigations performed by the manufacturing site or OEM supplier.
• Follow up with investigators on aging investigations.
• Perform final review for closure of non-reportable complaint files to ensure accuracy, completeness, and attention to detail.
• As needed, perform training on complaints for sales forces.
• Attend training on new products or changes to existing products.
• Generate results letters to customers.
• Follow up with International Business Centers regarding overdue results letters, if applicable.