Complaint Management Specialist I

4 weeks ago


Tempe, Arizona, United States BD (Becton, Dickinson and Company) Full time
Job Description Summary

The Complaint Management Specialist position plays a critical role in supporting and overseeing product complaint handling and Post Market Surveillance activities. This individual must possess a customer-centric focus while interacting with customers, as well as other team members in professional services and quality.

Effective interpersonal skills and professional customer communication skills (verbal & written) are required for outbound customer calls to obtain adverse event details in a timely and expeditious manner.

Key Responsibilities
  • Oversight and support of global compliant handling, including intake of complaints, investigation of complaints, and closure of complaints.
  • Collaboration with BD investigative lab and/or supplier(s) to pass on pertinent details quickly from customer calls or correspondence.
  • Monitoring of death or serious injury medical device report (MDR) records through investigation completion to closure, ensuring comprehensive and timely adverse event information.
  • Subject matter expertise for audits or assessments on adverse events.
  • Review and summarization of medical journal articles received throughout BD on PI devices to assess reportable adverse events for medical device reporting.
  • Raising awareness of adverse events to legal, corporate, and management teams.
  • Periodic review and revision of MDR Reportability Guidelines to incorporate current failure modes and reportability determinations.
  • Collaboration with peers/suppliers to ensure changes to automated tools are updated based on updated work instructions and MDR Reportability Guidelines.
Requirements
  • Bachelor's Degree in Engineering or Nursing, with a minimum of 3 years of professional experience directly related to the degree.
  • Experience in CAPA, QMS Auditing, Document/Change Control, Training, and Records Management, preferably in medical devices.
  • Ability to collect, analyze, and present clinical data, with proficiency in computer skills (Word, PowerPoint, Excel, etc.).
  • Effective interpersonal, telephone, and communication skills (both written and verbal).
  • Working experience with various software programs, including MS Office (Word, PowerPoint, Excel, and Outlook), with experience with TrackWise, SAP, and MS Teams preferred.
  • Understanding of regulatory requirements, including ISO 13485 and ISO 14971.
Why Join Us?

A career at BD means being part of a team that values your opinions and contributions, and encourages you to bring your authentic self to work. We welcome people with the imagination and drive to help us reinvent the future of health.



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