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.

What you’ll do

Manage calibration and preventive maintenance

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

Assist with documentation reviews

Review and approve basic nonconforming material reports
Review Device History Records (DHRs) to ensure we are producing compliant devices that consistently meet specifications

Perform basic quality inspections

Conduct or approve receiving activities to verify that purchased product meets requirements
Conduct basic quality inspections on the production line

Manage process validation

Perform installation qualification, operational qualification, and process qualification activities to ensure processes are functioning as intended when new and after changes

Enforce a strong quality culture

Ensure team members are aware of GMP principles
Identify and correct GMP lapses when necessary

Required experience

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

Preferred experience

Experience with FDA inspections or MDSAP audits
An engineering degree or equivalent experience
Mechanical aptitude

Manufacturing Quality Engineer