Senior Quality Lead: CAPA, Audits & Regulatory Excellence

Robotic Technologies Automation; Madison (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

ROBOTIC PROCESS AUTOMATION LLC is seeking a Quality Assurance professional to develop and maintain quality system processes, drive CAPA, and coordinate audits in a regulated environment. The role supports root cause analysis across cross-functional teams and leads Change Management initiatives.

The ideal candidate will apply Good Documentation Practice, ensure regulatory compliance, and contribute to continuous quality improvement through data-driven reporting and management reviews.

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

ROBOTIC PROCESS AUTOMATION LLC is seeking a Quality Assurance professional to develop and maintain quality system processes, drive CAPA, and coordinate audits in a regulated environment. The role supports root cause analysis across cross-functional teams and leads Change Management initiatives.

The ideal candidate will apply Good Documentation Practice, ensure regulatory compliance, and contribute to continuous quality improvement through data-driven reporting and management reviews.