Senior Quality Analyst/Engineer

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

Job Description :

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

MACHINE INTELLIGENCE TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. MACHINE INTELLIGENCE TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will MACHINE INTELLIGENCE TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract