(US REMOTE) Director of Quality Assurance : Remote Cardiac Monitoring

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.