At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at
Job Function: Quality
Job Sub Function: Quality Systems
Job Category: Professional
All Job Posting Locations: Irvine, California, United States of America, Jacksonville, Florida, United States of America
Job Description: Johnson & Johnson is currently recruiting for a
Compliance Analyst-Non-Product Software. This position can be located in Irvine, CA or Jacksonville, FL. Remote work may be considered on a case-by-case basis and if approved by the business.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at
Position Summary: We are seeking a highly skilled and detail-oriented Computerized Software Validation (CSV) Software Quality Engineer (SQE) to join our team in the healthcare industry. This role is crucial for ensuring that non-product software systems (NPS) meet regulatory standards and quality requirements, specifically in environments governed by FDA regulations and other healthcare compliance standards.
The NPS Quality Engineer will be responsible for ensuring that all computer systems and
software applications used within Vision are validated according to industry standards,
regulatory, and Johnson & Johnson requirements. The role involves collaborating
with cross-functional teams, conducting validation activities, documenting procedures,
and maintaining compliance records.
Key Responsibilities: - Develop and execute software validation strategies and plans for computerized systems in accordance with regulatory guidelines (e.g., FDA CSA, ISO 13485).
- Support establishing and maintaining the validation master plan for non-product software applications.
- Conduct periodic reviews, risk assessments and maintain risk management files for software quality activities.
- Create and implement validation documentation, including Validation Plans, Test Reports & Traceability Matrices.
- Lead/support collaboration with functional areas, partner with colleagues across JJV sites, to ensure GxP compliance for non-product software applications is established and maintained. Adopt a risk-based approach, ensuring compliance, efficiency and streamlining.
- Review and assess software change controls to ensure changes are fully verified and documented in appropriate change management software/forms. Also completed change impact analysis on interacting validated systems.
- Participate in audits and inspections related to software validation and quality assurance processes. Serve as process SME for JJV non-product software development life cycle (SDLC) during internal and external audits. Supports investigations/actions associated with non-conformances and CAPA.
- Stay updated with industry trends and regulatory changes related to software validation in the healthcare sector.
- Train and guide stakeholders on validation best practices and compliance requirements.
- SQE Site Lead for sites in California. Be able to work primarily during Pacific Time Zone working hours. Some flexibility may be needed.
- Understand and apply Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team.
Qualifications: Education: A minimum of a Bachelor's or equivalent University degree is required with a focus in Computer Science, Software Engineering, Biomedical Engineering, or a related field preferred.
Required: - A minimum of 4-6 years relevant work experience.
- Proven experience in software validation and quality assurance, particularly in the healthcare or life sciences industry.
- Strong knowledge of regulatory requirements concerning software development life cycle and software validation (e.g., 21 CFR Part 11, 210, 211 and 820).
- Familiarity with risk management methodologies such as ISO 14971.
- Proficiency in validation tools and techniques, Agile/SDLC Methodology as well as documentation standards (SOPs, protocols, reports).
- Excellent analytical and problem-solving skills, with a keen attention to detail.
- Strong communication skills and the ability to work collaboratively in a team environment.
Preferred Skills: - Familiarity with Artificial Intelligence and Machine Learning regulatory standards
- Experience in IP Security and Data Privacy
- Certification in Quality Assurance or Software Validation (e.g., ASQ CQA, CSM, or similar).
- Knowledge of Citizen Developed applications, automated testing tools and methodologies.
- Experience with validation software tools such as JIRA, XRay, qTest
Other:•This position has an estimated annual salary of 91,000 to 147,200 USD$
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k .
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
The anticipated base pay range for this position is : 91,000 to 147,200 USD$
Additional Description for Pay Transparency: •This position has an estimated annual salary of 91,000 to 147,200 USD$
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k . - Employees are eligible for the following time off benefits: - Vacation - up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year - Holiday pay, including Floating Holidays - up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year