Staff Quality Systems Analyst

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 .

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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 were 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 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 welldefined 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.

Key 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.

Qualifications

Education:

• Minimum of Bachelors or equivalent University degree in Science Engineering or a related discipline is required.

Experience and Skills:

Required:

• A minimum of six (6) years of professional experience working in a Quality related medical device or pharmaceutical manufacturing environment.

Preferred:

• 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.

Other:

• Proficiency (verbal and written) in the English language is required.
• Up to 10% travel may be required for this position.

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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