C. R. Bard, Inc.

Field Assurance Supervisor

5 days ago
Industry / Category
Field Assurance Supv/Quality
Job ID
2017-10293
Career Level
experienced
Division
Bard Medical
Relocation
Yes
US-GA-Covington

Overview

The 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

  • 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 for disposable medical devices and capital equipment for both domestic and international customers.
  • Ensures competent decision making skills are demonstrated by direct reports for complaint and reportability determinations.
  • Maintains customer focus through efficient and effective communications and follow-up on customer concerns, including reimbursement requests and response letters.
  • Ensures follow-up with customers and sales representatives to obtain additional information when necessary and to request return of overdue complaint samples.
  • 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.
  • Implement, review and update (as needed) the systems and processes for receiving and evaluating complaints.
  • 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.
  • Interacts with international facilities with reporting responsibilities to BMD in establishing standardization of complaint handling and MDR/vigilance compliance.
  • Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
  • Interprets corporate policies and regulations as they relate to Field Assurance, and prepares and implements Divisional procedures for conformance.
  • Manage complaint turnaround times and processing metrics.
  • Determines whether a product malfunction or serious injury report needs to be filed with the FDA. Determines whether a 30-day or 5-day MDR report is required. Ensures the necessary reports are filed with the appropriate regulatory body (FDA, Competent Authority, etc) within required timeframes.
  • Lead training on GMPs/complaint handling for new sales representatives.
  • Other duties as assigned.

Basic Qualifications

  • 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, engineering or technical field.
  • Minimum three years of experience with FDA regulated industry including experience in complaint handling, MDR/adverse event reporting, and complaint investigations.
  • Experience with Trackwise or electronic complaint handling preferred.
  • Minimum three years’ supervisory experience.
  • Minimum five years’ experience in Quality Assurance or Regulatory Affairs in a medical device environment.

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.

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