Senior Quality Analyst — Lead CAPA & Regulatory Excellence

Valiant Technologies LLC; Madison (WI); Presencial; USD 85 000 - 120 000; Tempo integral

Resumo da oferta

VALIANT TECHNOLOGIES LLC is seeking a QA/Quality Systems leader to develop and maintain quality system processes and metrics. The role will manage CAPA processes, review Quality Management activities, and lead Change Management initiatives across the site.

You will coordinate regulatory interpretations, support facility audits, and drive data collection for recalls, FDA-focused trending, and continuous improvement of procedures to meet regulatory requirements.

Qualificações

• Experience in quality systems and regulatory compliance.
• Ability to lead CAPA initiation, review, surveillance and reporting.
• Strong facilitation skills for site Quality Management reviews.
• Strong change management and root cause analysis capabilities.

Responsabilidades

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate the site Quality Management reviews.
• Lead the site Change Management process.
• Support and lead root cause analyses through cross functional team involvement.
• Lead Good Documentation Practice training and Quality on the Floor coordination and performance.
• Interpret and apply regulatory requirements.
• Coordinate and provide direct support for facility audits by internal and external entities.
• Manage data collection and reporting for product recalls.
• Perform trending of Quality Systems to support FDA and Management reviews.
• Improve quality culture through site initiatives and improve procedures to align with regulatory requirements.
• Review and approve procedures, protocols, reports, etc.

Descrição da oferta de emprego

VALIANT TECHNOLOGIES LLC is seeking a QA/Quality Systems leader to develop and maintain quality system processes and metrics. The role will manage CAPA processes, review Quality Management activities, and lead Change Management initiatives across the site.

You will coordinate regulatory interpretations, support facility audits, and drive data collection for recalls, FDA-focused trending, and continuous improvement of procedures to meet regulatory requirements.