Senior Quality Analyst: Quality Systems & CAPA Lead

Machine Intelligence Technologies, LLC; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

MACHINE INTELLIGENCE TECHNOLOGIES LLC is seeking a Quality Systems professional to develop and maintain quality system processes in a regulated environment. The role includes CAPA management, oversight of change control, and facilitating site quality reviews.

Responsibilities include coordinating audits, leading root cause analyses across functions, and ensuring compliance with applicable regulatory requirements. Prior experience in quality assurance and documentation control is essential.

Qualifications

• Knowledge of quality systems and regulatory requirements.
• Experience with CAPA initiation, review, and surveillance.
• Ability to lead root cause analyses and cross-functional investigations.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate site Quality Management reviews and Change Management processes.
• Lead root cause analyses with cross-functional teams.
• Coordinate facility audits and support regulatory inspections.
• Review and approve procedures, protocols, and reports as required.

Skills

Quality management

CAPA

Regulatory compliance

Cross-functional collaboration

Job description

MACHINE INTELLIGENCE TECHNOLOGIES LLC is seeking a Quality Systems professional to develop and maintain quality system processes in a regulated environment. The role includes CAPA management, oversight of change control, and facilitating site quality reviews.

Responsibilities include coordinating audits, leading root cause analyses across functions, and ensuring compliance with applicable regulatory requirements. Prior experience in quality assurance and documentation control is essential.