Manager Quality Systems

Responsibilities

• Lead and manage Issue Escalation RMB and Quality Review Board (QRB) processes, including:
• Coordinating information gathering across sites and stakeholders
• Preparing materials and conducting dry runs
• Documenting meeting minutes and tracking action items
• Oversee field corrective actions and regulatory follow-ups, including:
• Supporting global field action coordinators
• Assisting with product issue resolution tied to QRB and CAPA activities
• Ensure compliance across all escalation and field action activities by:
• Preparing documentation for reportable and recordable field actions
• Tracking customer communications for effectiveness
• Submitting interim status reports to the FDA
• Maintaining recall files (electronic and hard copy)
• Preparing monthly reports for leadership
• Drive process improvement initiatives and strategic programs to enhance systems and foster innovation
• Monitor Quality Management System (QMS) performance through metrics and analytics, identifying trends and implementing corrective actions
• Ensure team compliance with applicable regulations, including:
• FDA 21 CFR Parts 820, 210/211, and 4
• ISO 13485
• Global regulatory requirements (e.g., MHLW, ANVISA)
• Provide leadership and oversight for cross-functional processes and platforms across JJV, MedTech, and Enterprise teams
• Develop and maintain training and knowledge standards to ensure personnel are equipped to meet quality expectations
• Act as a subject matter expert (SME), identifying opportunities to strengthen QMS processes and compliance

Requirements

• Education:
• Bachelor's degree (or equivalent) required; preferred focus in Science, Engineering, or Business
• Skills & Capabilities
• Minimum of 6 years of experience in Quality, Regulatory, Supplier Quality, or a regulated industry
• Experience owning and executing quality system processes strongly preferred
• Demonstrated ability to collaborate cross-functionally and deliver business results
• Strong technical writing and documentation skills
• Experience supporting health authority or Notified Body inspections preferred
• Required Skills:
• Preferred Skills:
• The anticipated base pay range for this position is :
• $102,000.00 - $177,100.00
• Additional Description for Pay Transparency:
• Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation

Benefits

Additional Information

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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: Professional All Job Posting Locations: Irvine, California, United States of America, Jacksonville, Florida, United States of America Job Description: Johnson & Johnson is seeking a Manager, Quality Systems to lead and enhance escalation and field action processes while ensuring full compliance with global regulatory and corporate requirements. This position can be located in Jacksonville, FL or Irvine, CA Position Summary: This role is responsible for establishing, maintaining, and optimizing escalation processes and field action systems. The Manager will ensure alignment with local, national, and international regulations, as well as Johnson & Johnson policies and procedures.

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