Quality Systems Lead - CAPA, Audits & Compliance

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

Job summary

Machine Learning Technologies, LLC in Madison, WI seeks a Quality Assurance professional to develop and maintain quality system processes, lead CAPA and change management, and drive root cause analyses across cross-functional teams. You will coordinate regulatory interpretation and participate in facility audits with internal and external entities.

The role emphasizes Good Documentation Practice, Quality on the Floor training, data collection for recalls, and trending to support FDA reviews and

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
• We are an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, national origin, citizenship/ immigration status, veteran status, or any other status protected under federal, state, or local law.

Job description

Machine Learning Technologies, LLC in Madison, WI seeks a Quality Assurance professional to develop and maintain quality system processes, lead CAPA and change management, and drive root cause analyses across cross-functional teams. You will coordinate regulatory interpretation and participate in facility audits with internal and external entities.

The role emphasizes Good Documentation Practice, Quality on the Floor training, data collection for recalls, and trending to support FDA reviews and