The Legal Field Assurance Supervisor is located at C. R. Bard Medical Division in Covington, GA.
Summary of Position with General Responsibilities:
This position manages the Field Assurance Department from a global perspective and provides a high degree of confidence that all product complaints received on products manufactured and/or marketed by Bard Medical Division (BMD) and any of its business groups are documented and maintained in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures
Essential Job Functions:
- Implement, review and update (as needed) the systems and processes for receiving and handling complaints.
- Implement, review and update (as needed) the systems and processes, including the assessment tools for determining and reporting MDRs.
- Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file.
- Maintains customer goodwill through efficient and effective communications and follow-up on customer concerns.
- Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
- FDA-MDR contact for responding to FDA inquiries and for documentation and reporting of adverse events (both domestic and international) for products marketed by BMD.
- Ensures that all complaints on products marketed by BMD and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Divisional policies and procedures, and applicable regulations.
- Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations.
- Ensures that upper management is informed of potential recall situations and complaint and adverse event trends.
- Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
- Interprets corporate policies and regulations as to how they relate to Field Assurance, and prepare and implement Divisional procedures for conformance.
- Provides support to project teams in preparing FMEAs, establishing complaint handling, MDR reporting and servicing responsibilities via contracts, reviewing labeling and complaint history on similar products, and monitoring market tests.
- Interacts with international facilities with reporting responsibilities to BMD in establishing standardization of complaint handling and MDR/vigilance compliance.
- Develops and implements department DOPs and SOPs.
- Manage complaint turnaround times
- Handle FDA inquiries of complaints.
- Manage field actions including recalls and field notifications. Evaluate potential MDRs, conduct a risk analysis and obtain a HHE when necessary.
- Where a complaint should be an MDR, file the necessary report with the FDA within required timeframes.
- Determine whether a product malfunction or serious injury report 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.
- As needed, participate in training sessions for sales force.
- Lead training on GMPs/complaint handling for sales representatives.
- Other duties as assigned.
• Proficient in the use of a personal computer with intermediate level of keyboarding skills.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, telephone manner, professionalism, coaching, influencing, and team building.
• Strong listening and assessment skills.
• Strong questioning & problem-solving skills.
• Detail oriented, committed to accuracy, efficiency, and consistency.
• Good proofreading skills and memory retention.
• Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
• Must be able to manage people and control stressful situations.
• Must be able to maintain a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department.
• Must be able to maintain legible, accurate records
Additional Desirable Qualifications Skills and Knowledge:
- Must possess a professional image and demonstrate work maturity.
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
- Must be able to manage people and control stressful situations.
- Must be able to maintain a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department.
- Must be able to maintain legible, accurate records.
- Good written and verbal communication skills.
Education and/or Experience:
- Four-year degree in nursing, science or technical field.
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 is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...