Complaints Coordinator

  • Guilford, CT, USA
  • Full-time

Company Description

Butterfly Network has created and brought to market the Butterfly IQ – the first FDA-cleared, portable device that puts ultrasound technology on a semiconductor chip. Pairing ultrasound-on-a-chip with the cloud and AI, we are doing something never done before, and bringing ultrasound to new domains around the world. Since inception, Butterfly has raised over $375 million. As we scale our team, we are seeking the best and the brightest engineers, across both the software and hardware worlds.

Job Description

Complaints Coordinator is responsible for the day to day management of the
complaint handling process. This position collaborates closely with Customer Support, Product Integrity, Supplier Quality, Clinical and Operations/Engineering.


Key Responsibilities:
• Responsible for the oversight of customer communication and initial QA review to determine if the
information meets the definition of a complaint.
• Responsible for the customer complaint handling process, including logging complaints and
performing initial assessments to determine potential reportability, assignment of investigation,
coordination of investigation results and complaint closure.
• Responsible for assisting in the transition from a paper-based system to an electronic complaint
handling system.
• Operate as a System Administrator for the electronic complaint management system.
• Responsible for monitoring the complaint metrics and working with colleagues to ensure complaint
handling time requirements are met.
• Responsible for tracking and trending complaints and preparing complaint analysis reports,
highlighting any trends and initiating CAPAs as appropriate.
• Responsible for highlighting any potential reportable events to QARA Management as soon as
possible as per the Medical Device Reporting/Vigilance procedures.
• Responsible for preparing & presenting data regarding complaint metrics for Post Market
Surveillance and Management Review.
• Responsible for contributing to the continual quality of Butterfly Network’s process improvement
initiatives.
• Ensuring that policies, procedures and practices are in compliance with global regulatory
requirements and are aligned with our Quality Policy.
• Responsible for performing tasks to support the quality system and quality policy as directed by
QARA management, including audit support.

Qualifications

• Bachelors Degree required with 1 – 3 years of experience in medical device complaint handling
• Working Knowledge of ISO13485 / FDA QSR Part 820 / 803 requirements
• Knowledge of statistical data analysis tools and techniques, or willingness to learn
• Excellent interpersonal skills
• Ability to work in a timeline driven environment
• Excellent communication skills, both written & oral

Additional Information

In addition to working with colleagues and advisors who are the best and brightest in their fields, building a revolutionary product and helping to save lives, we offer great perks:

  • Fully funded medical insurance, dental and vision coverage
  • 401K plan
  • Competitive salary and equity in the company
  • Free on-site meals, unlimited healthy snacks
  • Beautiful office near the waterfront in historic Guilford, CT
  • Pre-tax commuter benefits

Butterfly Network is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability, or Veteran status.