Fortell is an AI hearing aid company. We’ve developed a breakthrough hearing aid leveraging AI and custom silicon. We launched our first product out of our own audiology clinic in New York four months ago, and are now expanding to new locations and new channels.
We’re hiring a Manufacturing Quality Engineer to manage good manufacturing practice and quality compliance at our manufacturing site in Danbury, CT.
Own calibration and preventive maintenance logs to ensure equipment is suitable for use
Work with the manufacturing team to schedule calibration and preventive maintenance activities while minimizing production downtime
Maintain calibration and preventive maintenance records
3–8 years of experience working in a medical device environment
Comfortable with key medical device standards and regulations, including ISO 13485, 21 CFR 820, and ISO 14971
Confident speaking up when identifying nonconformances or quality concerns
Organized, detail-oriented, and comfortable working in a fast-paced manufacturing environment
Excited to work hands-on and help build scalable quality systems at an early-stage company
Compensation Range: $95K - $130K
