Post Market Surveillance Coordinator
- Guilford, CT, USA
Butterfly Network is reinventing medical imaging and championing a new era of healthcare by creating the first ever pocket-sized, whole-body ultrasound device - the Butterfly iQ. This breakthrough technology has reduced the cost of the traditional ultrasound system by miniaturizing it onto a single semiconductor silicon chip. Our mission is to democratize healthcare by making medical imaging accessible to everyone around the world.
Since inception, Butterfly has raised over $375 million. The iQ is FDA-cleared and is being sold in hospitals and clinics around the globe.
Joining Butterfly Network is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.
The Post Market Surveillance 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.
As part of our team, your core responsibilities will be:
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 and 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.
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 and oral
Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):
Scaling in a global company
Corrective and Preventive Actions
We offer great perks:
- Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
- Competitive salaried compensation - we value our employees and show it
- Equity - we want every employee to be a stakeholder
- Pre-tax commuter benefits - we make your commute more reasonable
- Free onsite meals + kitchen stocked with snacks
- 401k plan - we facilitate your retirement goals
- Beautiful office near the ocean-front in historic Guilford, Connecticut
- The opportunity to build a revolutionary healthcare product and save millions of lives!
For this role, we provide visa assistance for qualified candidates.
Butterfly network does not accept agency resumes.
Butterfly Network Inc. is an E-Verify Company and is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.