Staff Quality Systems Analyst

Johnson & Johnson Innovative Medicine • Jacksonville, FL

2d • Onsite

About The Position

Johnson and Johnson Vision Care is recruiting for a Staff Quality Systems Analyst, specializing in Change Control, to be located in Jacksonville, Florida. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Together with Quality Systems Management, this position plays a key technical role in leading and supporting the effective execution of the sites’ Quality Management System (QMS), with a primary focus on the governance and execution of the Change Control process. The role requires strong technical expertise to assess, advise on, and support changes impacting validated systems, manufacturing processes, equipment, software, and quality documentation, ensuring appropriate risk assessment, validation strategy, and regulatory compliance. This position ensures Quality Systems are technically robust, well‑defined, and consistently executed in alignment with J&J standards and global regulatory requirements, while meeting customer and business needs. The individual will partner closely with Engineering, Manufacturing, IT, Validation, and Regulatory stakeholders, and liaise with Franchise, Sector, and Enterprise teams to drive harmonization, standardization, and simplification across Change Control and other key QMS processes and systems.

Requirements

• Minimum of Bachelors or equivalent University degree, in Science, Engineering or a related discipline is required.
• A minimum of six (6) years of professional experience working in a Quality related medical device or pharmaceutical manufacturing environment.
• Proficiency (verbal and written) in the English language is required.

Nice To Haves

• Technical experience in change control and validation systems/processes.
• Advanced knowledge of external standards and regulations such as ISO 13485:2016, 21 CFR 820.
• Advanced knowledge of Quality and Compliance techniques and principles.
• Proven success in the execution and application of quality systems, including the application of risk management and statistical methods.

Responsibilities

• Serve as the technical quality system subject matter expert (SME) for Change Control, providing authoritative guidance on changes impacting validated computerized systems, manufacturing processes, equipment, automation, software, and quality system documentation.
• Provide end-to-end technical quality oversight of the Change Control lifecycle, ensuring changes are appropriately classified, risk assessed, validated, and implemented in compliance with regulatory requirements (e.g., GMP, GxP, data integrity).
• Proactively review and enhance Change Control processes, procedures, and system configurations to drive improvements, simplification & harmonization.
• Develop and deliver expert technical training and mentoring to system users, approvers, and functional stakeholders, ensuring consistent and compliant use of the Change Control system and associated procedures.
• Continuously assess and monitor system performance, efficiency and effectiveness, reporting change control metrics to maintain >90% green status.
• Support Quality Systems Inspection Readiness and internal/external audit execution as Change Control and Quality Systems SME as required.
• Coach and mentor cross functional partners, building technical capability in change management, risk assessment, validation, and data driven decision making.
• Develops, plans, and leads cross-functional quality systems projects ensuring technical deliverables, timelines, and compliance objectives are met.
• Act as delegate for the Senior Manager, Quality Systems, providing technical support and leadership across other QMS processes as required, including CAPA, nonconformance management, trending and analysis, and management review data preparation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees