BD (Becton, Dickinson and Company) Field Assurance Specialist I in Covington, Georgia
Job Description SummaryThe 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.
Provides assistance in all areas of complaint handling and adverse event reporting 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.
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 non-reportable 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 Medical Device Report (MDR) determination and document rationale for not filing in MDR decision tree
Perform MDR/adverse event reporting by submitting initial and supplemental MDRs.
Analyze complaints, quality investigations, and adverse events to ensure consistency, attention to detail, and correct coding
Other duties as assigned
Primary Work LocationUSA GA - Covington BMD
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.