Manufacturing Quality Engineer

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 doManage calibration and preventive maintenanceOwn calibration and preventive maintenance logs to ensure equipment is suitable for useWork with the manufacturing team to schedule calibration and preventive maintenance activities while minimizing production downtimeMaintain calibration and preventive maintenance recordsAssist with documentation reviewsReview and approve basic nonconforming material reportsReview Device History Records (DHRs) to ensure we are producing compliant devices that consistently meet specificationsPerform basic quality inspectionsConduct or approve receiving activities to verify that purchased product meets requirementsConduct basic quality inspections on the production lineManage process validationPerform installation qualification, operational qualification, and process qualification activities to ensure processes are functioning as intended when new and after changesEnforce a strong quality cultureEnsure team members are aware of GMP principlesIdentify and correct GMP lapses when necessaryRequired Experience3–8 years of experience working in a medical device environmentComfortable with key medical device standards and regulations, including ISO 13485, 21 CFR 820, and ISO 14971Confident speaking up when identifying nonconformances or quality concernsOrganized, detail-oriented, and comfortable working in a fast-paced manufacturing environmentExcited to work hands-on and help build scalable quality systems at an early-stage companyPreferred ExperienceExperience with FDA inspections or MDSAP auditsAn engineering degree or equivalent experienceMechanical aptitudeCompensation Range: $95K - $130K