Senior Quality Engineer/Analyst

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.

• 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

• Perform or manage internal audits

• Manage supplier monitoring and qualification activities, including supplier audits

• Lead cross-functional teams in identifying systemic nonconformances

• Drive root cause investigations, corrective and preventive action planning and implementation, and verification of effectiveness

• 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

• 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

• 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

• 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

• 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

• Experience participating in MDSAP, ISO 13485, EU MDR audits, or FDA inspections

• Experience with IEC 60601-1 and other medical device standards

• Experience with EU MDR and UKCA requirements
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