Senior Quality Analyst/Engineer

Valiant Technologies LLC; Madison (WI); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

VALIANT TECHNOLOGIES LLC is seeking a QA/Quality Systems leader to develop and maintain quality system processes and metrics. The role will manage CAPA processes, review Quality Management activities, and lead Change Management initiatives across the site.

You will coordinate regulatory interpretations, support facility audits, and drive data collection for recalls, FDA-focused trending, and continuous improvement of procedures to meet regulatory requirements.

Competenze

• Experience in quality systems and regulatory compliance.
• Ability to lead CAPA initiation, review, surveillance and reporting.
• Strong facilitation skills for site Quality Management reviews.
• Strong change management and root cause analysis capabilities.

Mansioni

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate the site Quality Management reviews.
• 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 and performance.
• Interpret and apply regulatory requirements.
• Coordinate and provide direct support for facility audits by internal and external entities.
• Manage data collection and reporting for product recalls.
• Perform trending of Quality Systems to support FDA and Management reviews.
• Improve quality culture through site initiatives and improve procedures to align with regulatory requirements.
• Review and approve procedures, protocols, reports, etc.

Descrizione del lavoro

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

VALIANT 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. VALIANT 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 VALIANT 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