Senior Quality Systems Analyst: CAPA, Audits & Compliance

Ethereum Technologies LLC; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Ethereum Technologies LLC is seeking a Quality Systems professional to develop and maintain quality processes, manage CAPA initiation and reviews, and lead change management across the site. You will support audits, data reporting, and regulatory compliance to ensure product quality and patient safety in Madison, Wisconsin.

The role emphasizes root cause analysis, cross-functional collaboration, training, and continuous improvement to strengthen quality culture and alignment with applicable

Responsibilities

• 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

Job description

Ethereum Technologies LLC is seeking a Quality Systems professional to develop and maintain quality processes, manage CAPA initiation and reviews, and lead change management across the site. You will support audits, data reporting, and regulatory compliance to ensure product quality and patient safety in Madison, Wisconsin.

The role emphasizes root cause analysis, cross-functional collaboration, training, and continuous improvement to strengthen quality culture and alignment with applicable