Manager Quality Systems

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Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States;
Jacksonville, Florida, United States

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.

• 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, Med Tech, 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

• 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: Experience with Corrective and Preventive Action (CAPA), Quality/Incident Management, Quality Management Systems (QMS)

Preferred: Experience in Collaboration, Compliance Management, Data Quality, Developing Others, Quality Standards, Risk Management, System Integration, Systems Analysis, Team Management

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other…