Under the leadership of the Manager of Field Assurance and supervision of the Supervisor of Field Assurance, the Field Assurance Analyst will be responsible for the initiation of product complaint handling activities while ensuring tasks are completed as required and compliant to internal standards/procedures and applicable external, industry regulations/standards.
Summary of Position with General Responsibilities:
Receive and process complaint information from all sources.
Perform clinical severity and risk assessments for complaint events.
Follow up with complainants to obtain additional information and product samples as necessary.
Process medical record information to support complaint information.
Act as liaison with internal and external resources throughout complaint handling activities.
Assess complaint information and determine if the event meets regulatory Medical Device Report (MDR) submission requirements.
Maintain thorough and accurate complaint records.
Utilize Enterprise Resource Planning (ERP) systems for product-related inquiries and transactions.
Complete project tasks as assigned.
Identify and escalate quality issues.
Complete mandatory training by established due dates and maintain training compliance at all times.
Adhere to departmental processes and systems to ensure regulatory compliance.
Graduate of accredited LPN or RN certificate program.
2-5 years complaint handling experience.
Working knowledge of medical device terminology as well as anatomical and physiological terminology.
Working knowledge of medical device, pharmaceutical or biotech industry and regulatory requirements.
Sound written and verbal communication, problem solving and applied thinking skills.
Strong proficiency in common computer applications such as Microsoft Office (Excel, Word and Outlook).
Team player with ability to successfully interact with representatives from a variety of disciplines within and external to Davol and CR Bard.
Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
Must be self-motivated, self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
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...