BD (Becton, Dickinson and Company) Field Assurance Specialist in Tempe, Arizona
Job Description Summary
The Field Assurance Specialist (FA) initiates domestic and/or OUS complaints, gathers event information, determines reportability per FDA regulations, submits regulatory reports, and provides feedback to the customer, if appropriate. The FA Specialist also provides complaint detail to management, project teams and engineering, as requested.
Document the complaints received by internal customers (i.e. Bard Sales Reps, CS&S personnel, etc.) and external customers (i.e. physicians, patients, etc.).
Communicate with internal and external customers to gather additional patient, product, and procedural details related to the complaint record.
Evaluate the alleged deficiency to determine if the event meets the definition of a complaint per 21 CFR 820.3.
Enter event into the electronic complaint handling database within the allotted timeframe.
Assess event for reportability in accordance with FDA regulations (21 CFR 803).
Submit medical device reports (MDRs) and/or competent authority reports to the identified regulatory agency.
Complete all complaint records in a timely and accurate manner.
Assure timely complaint closure, meeting both internal and external requirements and metrics, by tracking and monitoring complaint records and samples from the customer through complaint record closure.
Acknowledge receipt of complaint and generate closure letters, as appropriate.
Complete QA/FA and FA approvals of the investigation records.
Responsible for the secure and accurate maintenance of shared spreadsheets.
Monitor product complaints for potential trends.
Work in partnership with Engineering to obtain pertinent details that will assist in the investigation and identification of potential root cause of the device malfunction.
Advanced computer skills including database management, spreadsheet, and word processing
Knowledge of ISO, FDA Quality System Regulations, Good Manufacturing Practices (GMP)
Must have attention to detail and ability to prioritize workload
Must read, write, and understand English
Must have good organizational and problem solving skills
Must be experienced in handling detailed, confidential information/data
Skilled in communicating clearly and concisely, both oral and written
•Skilled in the understanding of business English usage, spelling, grammar and punctuation.
Bachelor’s degree in technical field and 0-1 years experience in healthcare/medical device manufacturing environment.
Primary Work LocationUSA AZ - Tempe BPV Building 4
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