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Manager Quality SystemsJ&J Family of Companies • Irvine, California, United States
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Manager Quality Systems

J&J Family of Companies
  • US
    Irvine, California, United States
  • US
    Irvine, California, United States
Jetzt Bewerben

Über

Manager, Quality Systems

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:
    • 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

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

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 characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $102,000.00 - $177,100.00

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 period 10 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

  • Irvine, California, United States

Sprachkenntnisse

  • English
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