Manager Quality Systems

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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:

  • 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:

Bachelors 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 . internal employees contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

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Manager