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 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