The Mullings Group · 3 days ago

Director of Quality Assurance

United States

Full-time

Remote

Director

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Health CareMedical

Growth Opportunities

Hiring Manager

Wesley Kennedy-Sita

Insider Connection @The Mullings Group

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Responsibilities

Oversee and maintain HW & SW product quality including QMS design and implementation.

Ensure FDA regulatory compliance, manufacturing and supplier QA, and risk assessment.

Establish proper audit and inspection protocols.

Lead efforts to ensure QMS compliance with FDA regulations (21 CFR 820), ISO standards, and other relevant regulatory bodies.

Investigate and analyze product and process non-conformities, identifying root causes and implementing corrective and preventive actions.

Utilize statistical tools and methodologies for data analysis.

Develop and maintain quality management systems.

Qualification

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Quality AssuranceQuality EngineeringQMS ComplianceFDA RegulationsISO StandardsRegulatory ComplianceRoot Cause AnalysisCorrective ActionsPreventive ActionsStatistical ToolsData AnalysisQuality Management Systems

Required

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.