The Field Assurance Specialist positions are located at C. R. Bard Medical Division in Covington, GA.
Summary of Position with General Responsibilities:
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. 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:
Generates results letters to customers.
- Perform complaint and quality investigations related to manufacturing, design or clinical use issues. Review and approve investigations performed by the manufacturing site or OEM supplier. Ensure consistency and attention to detail in performing and documenting complaint investigations.
- Ensures that the manufacturing sources are notified of all complaints received on products they manufactured and that complaint samples, when received, are forwarded to the manufacturing sources in a timely manner.
- For investigations, ensure consistency and attention to detail in performing and documenting complaint investigations.
- Perform final review for closure of complaint files to ensure accuracy, completeness, and attention to detail.
- Evaluates complaints for determining MDR/Vigilance events and document rationale for not filing MDRs.
- Determine whether a product malfunction or serious injury reports needs to be filed with the FDA. Determine whether a 30 day or 5 day MDR report is required. Maintain the records of all MDRs and document rationale for not filing MDRs.
- Create MDRs for review by the Clinical Risk Specialist.
- Create inquiry reports to the hospitals on reported complaints.
- Arrange for the return of complaint samples.
- Receive complaints and follow-up to collect relevant information from the user.
- Follow-up with customers and sales representatives to obtain additional information when necessary and to request return of overdue 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.
- Interaction with International Field Assurance personnel as required.
- Performs final review for closure of complaint files to ensure accuracy, completeness, and attention to detail.
- As needed, participate in training sessions for sales forces.
Maintain all required records for the complaint.
Approve vigilance/international competent authority report to authorities.
Approve decision trees for vigilance reports/international competent authority
Handle competent authority inquiries of complaints.
- Other duties as assigned.
Education and/or Experience:
- 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 in the use of a personal computer with basic level of Microsoft office skills.
- Must be knowledgeable of Bard Products (how used, and how they may fail).
- Good proofreading skills and memory retention skills.
- Ability to multitask.
- Must be able to work in a team environment.
Minimum four years of experience with FDA regulated industry including two years in medical complaint handling and MDR/adverse event reporting
- BS/BA degree required. Clinical experience preferred.
- Experience with Trackwise or electronic complaint handling required.
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.
C. R. Bard - 2 years ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...