Field Assurance Specialist

Position : Field Assurance Specialist

Location : Covington, GA

Duration : 6 Months Contract

Total Hours/week : 40.00

1st shift

Job Summary:

• 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.

Summary of Position with General Responsibilities:

• Provides assistance in all areas of complaint handling to ensure that the duties of the department are performed in an accurate and timely manner.

Essential Job Functions:

• 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.
• Follow-up with investigators when investigations are aging.
• Review and approve investigations performed by the manufacturing site or OEM supplier. - Performs final review for closure of complaint files to ensure accuracy, completeness, and attention to detail.
• Attends training on new products or changes to existing products.
• Generates results letters to customers.
• Evaluate complaints for Adverse Event/Medical Device Report (MDR) determination and document rationale for not filing in the decision tree.
• Perform MDR/adverse event reporting by submitting initial and supplemental reports.
• Analyze complaints, quality investigations, and adverse events to ensure consistency, attention to detail, and correct coding.
• Other duties as assigned

Basic Qualifications:

• Excellent oral and written communication skills and telephone presence/manner.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone courtesy, professionalism, and influencing.
• Must be able to comprehend and apply QSR and FDA regulations.
• Detailed oriented - committed to accuracy, efficiency, and consistency.
• Must be capable of drafting own correspondence with hospitals and end users.
• Proficient Microsoft Office with a minimum of a basic skill level in Microsoft Excel.
• Good proofreading skills and memory retention skills.
• Ability to multitask and work in a fast-paced environment.
• Must be able to work in a team environment.

Education and/or Experience:

• BS/BA degree required.
• Clinical experience preferred.
• Experience with Track Wise or electronic complaint handling preferred.
• Preferred experience with FDA regulated industry including, medical complaint handling and MDR/adverse event reporting

Physical Demands:

• While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision.

Work Environment:

• This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards. Must be trained in blood-borne pathogens and handling bio-hazardous materials.