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Wesley Kennedy-Sita
Global Medtech Executive Recruitment : Start-up -> Fortune 500 : IC -> C-Level : Emerging Medtech Trends & Insights
Director of Quality Assurance
AI Enabled Remote Cardiac Monitoring
US Remote : FTE Immediate Direct Hire
QMS Development : Product/Manufacturing/Supplier QA: Risk Management
Our retained client is a fast-growing cardiac remote monitoring start-up that's developed an innovative proprietary vectorelectrocardiography (VECG) technology that collects 3D signals of the heart’s electrical activity and converts them into a 12-lead ECG.
This novel AI-enabled wireless cardiac monitoring solution has the potential to revolutionize the standard of heart failure care by providing physicians with real-time vivid 3D cardiac ECG data to identify and prevent life-altering cardiac events.
Currently this organization is seeking a new well-tenured Director of Quality Assurance to oversee and maintain HW & SW product quality including QMS design and implementation, FDA regulatory compliance, manufacturing and supplier QA, as well as risk assessment establishing proper audit and inspection protocols.
Qualifications:
Bachelor's degree in a relevant field; advanced degree preferred.
Proven experience in quality assurance and quality engineering for medical devices, with a proven track record of leadership.
Lead efforts to ensure QMS compliance with FDA regulations (21 CFR 820), ISO standards (e.g., ISO 13485, 14971), and other relevant regulatory bodies.
Investigate and analyze product and process non-conformities, identifying root causes and implementing corrective and preventive actions (CAPA).
Familiarity with statistical tools and methodologies for data analysis.
Demonstrated experience in developing and maintaining quality management systems.
Seniority level
Director
Employment type
Full-time
Job function
Manufacturing and Quality Assurance
Industries
Medical Equipment Manufacturing
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