Quality Systems Manager

Johnson & Johnson

Manager of Quality Systems at Johnson & Johnson leading compliance and process enhancement efforts. Driving initiatives across Quality Management Systems and regulatory adherence in the healthcare innovation sector.

Posted 7/1/2026full-timeJacksonville • California, Florida • 🇺🇸 United StatesMid-LevelSenior💰 $102,000 - $177,100 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

Bachelor’s degree (or equivalent) required; preferred focus in Science, Engineering, or Business
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

Benefits

Comp & perks

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)).
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

ATS Keywords

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Hard Skills & Tools

Quality System ProcessesRegulatory RequirementsField Corrective ActionsMetrics and AnalyticsDocumentation PreparationAction Item TrackingIssue ResolutionTraining DevelopmentSubject Matter Expertise (SME)Inspection Support

Soft Skills

LeadershipCollaborationCommunicationProblem-SolvingInnovation