Senior Quality Engineer/Analyst

Fortell is an AI hearing aid company that has developed a breakthrough hearing aid leveraging AI and custom silicon. They are hiring an experienced Quality Engineer to own key quality processes as they expand their business and product line.

Responsibilities:

• 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

Requirements:

• 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