Field Assurance Specialist

Job Description

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.

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.
• Matches any returned samples with their corresponding complaint files and performs 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.
• Performs 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.
• Attends training on new products or changes to existing products.
• Generates results letters to customers.
• Follow-up with International Business Centers regarding overdue results letters, if applicable.

Skills

• Strong communication and interpersonal skills
• Ability to work independently and manage multiple tasks
• Attention to detail and accuracy
• Knowledge of regulatory requirements and quality systems