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.
Key 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:
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
Qualifications:
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 –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
