Senior Quality Systems Leader

Johnson & Johnson MedTech; Cincinnati (OH); In loco; USD 150.000 - 210.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson MedTech is seeking a Senior Manager, Quality Management Systems to lead the strategy, governance, and global compliance of the Quality Management System across Auris sites. This role partners with Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical to ensure scalable, compliant processes that support product quality through the lifecycle.

The Senior Manager will drive digital transformation initiatives, champion data-driven quality improvement, and

Competenze

• Lead strategy and governance for the Quality Management System.
• Ensure regulatory compliance with FDA QSR, ISO 13485, EU MDR.
• Collaborate with Quality, Compliance, R&D, Supply Chain and Regulatory Affairs.

Mansioni

• Develop and execute the strategic roadmap for QMS across sites.
• Drive enterprise-QMS optimization for efficiency and scalability.
• Lead teams supporting Document Control, Training, CAPA, Records Management.
• Oversee inspection readiness and audit remediation programs.

Conoscenze

Quality Systems

Regulatory Compliance

Leadership

Cross-functional collaboration

Digital Transformation

Descrizione del lavoro

Johnson & Johnson MedTech is seeking a Senior Manager, Quality Management Systems to lead the strategy, governance, and global compliance of the Quality Management System across Auris sites. This role partners with Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical to ensure scalable, compliant processes that support product quality through the lifecycle.

The Senior Manager will drive digital transformation initiatives, champion data-driven quality improvement, and