Senior Quality Analyst/Engineer

Quantum Technologies. LLC; Madison (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

A technology company in Madison, Wisconsin is seeking a Quality Management professional to develop and maintain quality system processes. The candidate will manage CAPA activities, lead audits, support root cause analyses, and drive improvements to align with regulatory requirements. This role offers an opportunity to lead documentation practices and quality initiatives in a dynamic environment.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate and lead the site Change Management process.
• Support and lead root cause analyses through cross functional team involvement.
• Lead Good Documentation Practice training and Quality on the Floor coordination.
• Interpret and apply regulatory requirements.
• Provide support for facility audits by internal and external entities.
• Manage data collection and reporting for product recalls.
• Perform trending of Quality Systems to support reviews.
• Improve quality culture and existing procedures.

Job description

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

QUANTUM 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. QUANTUM 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 QUANTUM 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