Senior Manager, Quality Management Systems

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
People Leader

All Job Posting Locations:
Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America

Job Description:

We are searching for the best talent for Senior Manager, Quality Management Systems to join our MedTech Quality organization located in Santa Clara, CA or Cincinnati, OH.

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

The Senior Manager, Quality Management Systems (QMS) is responsible for leading the strategy, governance, continuous improvement, and global compliance of the Quality Management System across Auris sites.

This role serves as a key leader in driving quality excellence, inspection readiness, operational effectiveness, and digital transformation initiatives that support business growth, regulatory compliance, and product quality throughout the product lifecycle.

The position partners with cross-functional leaders across Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical to ensure the QMS remains scalable, efficient, and compliant with global regulatory requirements, including FDA QSR, ISO 13485, EU MDR, and other global regulations/standards.

Key Responsibilities

Quality Management System Leadership

• Develop and execute the strategic roadmap for the Quality Management System, ensuring alignment with business objectives, regulatory requirements, and industry best practices.

• Drive enterprise-wide QMS optimization initiatives to simplify, standardize, and improve quality processes, enhancing compliance, efficiency, and scalability.

• Lead teams supporting: Document Control, Training Management, CAPA, Records Management and additional Quality Subsystems as assigned

• Establish performance metrics and monitoring mechanisms to assess QMS effectiveness and drive a culture of continuous improvement.

Regulatory Compliance and Ins...