Senior Quality & Compliance Lead

Artifintech; Madison (WI); Sur place; USD 85 000 - 125 000; Plein temps

Résumé du poste

ARTIFICIAL INTELLIGENCE TECHNOLOGIES LLC in Madison, WI is seeking a Quality Assurance Lead to develop and maintain quality system processes, manage CAPA, lead change management, and support regulatory audits.

You will drive root cause analyses, perform data trending for FDA readiness, train staff in Good Documentation Practice, and coordinate documentation to ensure ongoing compliance across the site.

Responsabilités

• Develop and maintain quality system processes, including metrics reporting and tracking
• Manage CAPA initiation, review, surveillance, and reporting
• Facilitate the site Quality Management reviews
• Facilitate and lead the site Change Management process
• Support and lead root cause analyses through cross functional team involvement
• Leading Good Documentation Practice training and Quality on the Floor coordination and performance
• Interpret and properly apply all applicable regulatory requirements
• Coordinate and provide direct support for facility audits by internal and external entities
• Manage data collection and reporting when product recalls are required
• Perform trending of Quality Systems to support FDA and Management reviews
• Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
• Review and approval of procedures, protocols, reports, etc., as required.
• Filing and management of documentation when required
• Supporting other Quality System Functions
• This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need

Description du poste

ARTIFICIAL INTELLIGENCE TECHNOLOGIES LLC in Madison, WI is seeking a Quality Assurance Lead to develop and maintain quality system processes, manage CAPA, lead change management, and support regulatory audits.

You will drive root cause analyses, perform data trending for FDA readiness, train staff in Good Documentation Practice, and coordinate documentation to ensure ongoing compliance across the site.