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 an experienced Quality Engineer to own key quality processes as we expand our business and product line.

What you’ll do

Own quality metrics

Work with process owners to establish KPIs, including metrics, collection frequency, and action thresholds
Create monthly KPI reports, assign required actions, and document completed actions
Analyze data for management review, postmarket surveillance activities, and other quality assessments

Conduct audits

Perform or manage internal audits
Manage supplier monitoring and qualification activities, including supplier audits

Lead corrective and preventive actions

Lead cross-functional teams in identifying systemic nonconformances
Drive root cause investigations, corrective and preventive action planning and implementation, and verification of effectiveness

Maintain design control documentation

Ensure requirements documents and verification and validation protocols remain up to date following design changes
Maintain risk documentation, including design, use, and process risk analyses in response to design changes, design V&V activities, and postmarket data

Manage software releases

Provide quality guidance for software releases, including identification of required testing for each release
Ensure software change orders contain all required documentation to support compliant software releases
Ensure software problem reports are created, documented, and resolved within established timelines

Lead international launch efforts

Perform gap analyses between current technical files and requirements for intended launch regions
Lead cross-functional teams to address identified gaps
Complete regulatory submissions as needed
Support third-party audits required to obtain international certifications

Implement and improve the eQMS

Lead implementation of an improved electronic quality management system (eQMS)
Manage the transition from the existing document control system to the improved system
Conduct or manage quality management system software validations

Required Experience

5+ years of experience working in a medical device environment in a quality or regulatory role
Strong ability to manage multiple projects and priorities simultaneously
Working knowledge of ISO 13485, 21 CFR 820, IEC 62304, and ISO 14971
Comfortable operating cross-functionally and driving initiatives in a fast-paced environment
Organized, detail-oriented, and excited to build scalable quality systems at a growing company
Confident identifying issues, driving resolution, and holding a high quality bar