Senior Manager, QMS & Digital Quality Transformation

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson MedTech in Santa Clara, CA (or Cincinnati, OH) seeks a Senior Manager, Quality Management Systems to lead strategy, governance, and global compliance of the QMS across Auris sites.

This role partners with Quality, Compliance, R&D, Supply Chain and Regulatory Affairs to ensure QMS is scalable, efficient, and compliant with FDA QSR, ISO 13485, EU MDR, and other global standards.

Qualifications

• Proven experience leading global QMS programs and governance.
• Strong knowledge of FDA QSR, ISO 13485, EU MDR and related standards.
• Experience coordinating across Quality, Compliance, R&D, and Regulatory.

Responsibilities

• Develop and execute the strategic roadmap for the Quality Management System.
• Drive enterprise-wide QMS optimization to standardize and improve processes.
• Lead teams supporting Document Control, Training Management, CAPA, Records Management.
• Establish performance metrics to monitor QMS effectiveness and drive continuous improvement.

Skills

Quality Systems

Regulatory Compliance

Inspection Readiness

Leadership

Digital Transformation

Quality Governance

Job description

Johnson & Johnson MedTech in Santa Clara, CA (or Cincinnati, OH) seeks a Senior Manager, Quality Management Systems to lead strategy, governance, and global compliance of the QMS across Auris sites.

This role partners with Quality, Compliance, R&D, Supply Chain and Regulatory Affairs to ensure QMS is scalable, efficient, and compliant with FDA QSR, ISO 13485, EU MDR, and other global standards.