(US REMOTE) Director of Quality Assurance : Remote Cardiac Monitoring
(US REMOTE) Director of Quality Assurance : Remote Cardiac Monitoring
The Mullings Group
United States
See who The Mullings Group has hired for this role
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.
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Seniority level
Director -
Employment type
Full-time -
Job function
Manufacturing and Quality Assurance -
Industries
Medical Equipment Manufacturing
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