C. R. Bard, Inc.

Clinical Field Assurance Specialist- Temporary

3 weeks ago
Industry / Category
Medical Device/Quality Assurance
Job ID
2017-10826
Career Level
experienced
Division
Tempe, AZ/BPV
Relocation
No
US-AZ-Tempe

Overview

Bard Peripheral Vascular is located Tempe, AZ – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Summary of Position with General Responsibilities

Provide clinical/medical insight into the complaint handling process at Bard Peripheral Vascular. This is a temporary position expected to last about 3 months.

Essential Job Functions

  • Responsible for customer complaints to assess, evaluate, and determine MDR reportability per FDA guidelines.
  • Participate in decision making and/or the review process related to global reporting determinations.
  • Participate in creation and maintenance of MDR Reportability Guideline documentation.
  • Responsible for completing medical record and journal article reviews related to product complaints.
  • Assess the clinical severity level and document in the complaint record.
  • Provide clinical and technical assistance and/or training to the Field Assurance personnel.
  • Interface with hospital Risk Management and physicians involving complex adverse events.
  • Interface with internal/external customers with regard to the clinical impact of the product and customer dissatisfaction. Perform customer site visits, as necessary.
  • Draft and/or review customer results letters related to complaints.
  • Support internal, Corporate, and external regulatory audits.

Basic Qualifications

Strong organizational and analytical skills.

Excellent communication skills, both written and oral.

Ability to interact effectively with internal and external customers

Additional Desirable Qualifications Skills and Knowledge

Prior training and knowledge in the review and analysis of x-ray, CT, and other medical imaging related to customer complaints.

Education and/or Experience

  • RN or other appropriate clinical license or degree required.
  • Minimum one (1) year clinical and/or medical device experience preferred.
  • Knowledge and/or experience with FDA Quality System Regulations and Guideline and related quality standards.
  • Computer proficiency with standard software programs, i.e. Microsoft Office.

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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