Complaints Management Specialist

Position

Complaints Management Specialist

Covington, GA

9 Months contract

40.00 hours

1st Shift

Medical Device Company

Healthcare

Mid-Level

Contract on W2 (U.S. citizens or GC holders only)

Bachelor degree required

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.

• 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.