Sr Quality Engineer, NPS CSV

Johnson & Johnson • Santa Clara, CA

3d • Onsite

About The Position

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 Johnson & Johnson is recruiting for a Senior Quality Engineer, NPS CSV located in Santa Clara, CA. This is an onsite role. The Senior Quality Engineer- NPS CSV provided Quality Assurance oversight for non-product software systems used in GxP regulated environments including systems supporting Manufacturing, Quality, Clinical and R&D Operations. Working closely with cross-functional stakeholders, the Senior Quality Engineer ensures NPS are validated, controlled, and maintained in a compliant state using a risk-based Computer Software Assurance (CSA) approach. The role acts as a subject-matter expert for NPS quality throughout the system lifecycle, enabling compliant system deployment, effective change management, and sustained regulatory readiness. Additional responsibilities include supporting Quality Management System activities related to CAPA, deviations, nonconformances, software issue resolution, and internal and external audits, as applicable to non-product software.

Requirements

• Minimum 6 years of experience in Quality Assurance or Quality Engineering with a focus on software, including software verification and validation and risk management.
• Minimum 4 years of experience in a quality role within a regulated industry such as medical devices, pharmaceuticals, biotechnology.
• Strong knowledge of software validation and Computer Software Assurance (CSA) principles, including intended use–based and risk-based approaches.
• Working knowledge of applicable regulations and standards, including 21 CFR Part 11, 21 CFR Part 820, EU Annex 11, and FDA software validation guidance.
• Experience supporting or leading CAPA, deviation, nonconformance, and change control activities related to software and digital systems.
• Ability to support internal, supplier, and regulatory audits, including preparation, participation, and response development.
• Strong written and verbal communication skills, with the ability to clearly present quality risks, decisions, and recommendations to cross-functional stakeholders.
• Demonstrated ability to manage multiple priorities, work independently, and adapt in a fast-paced, evolving environment.

Nice To Haves

• Coaching
• Consistency
• Controls Compliance
• Critical Thinking
• Data Savvy
• Engineering
• Financial Competence
• Good Automated Manufacturing Practice (GAMP)
• ISO 9001
• Lean Supply Chain Management
• Leverages Information
• Process Improvements
• Quality Control (QC)
• Quality Standards
• Quality Systems Documentation
• Quality Validation
• Science
• Technology
• Engineering, and Math (STEM) Application
• Technologically Savvy

Responsibilities

• Provide Quality Assurance oversight for Non-Product Software (NPS) supporting Manufacturing, Quality, Clinical, and R&D operations across the organization.
• Ensure NPS systems are validated, maintained, and operated in compliance with FDA CSA guidance, 21 CFR Part 11, EU Annex 11, and internal Quality Management System (QMS) requirements.
• Review and approve NPS validation strategies, intended use and risk assessments, and execution approaches using critical thinking and CSA principles.
• Review and approve validation deliverables and evidence, including qualification activities (IQ/OQ/PQ where applicable), test summaries, validation summary reports, and release documentation to support system go-live and ongoing compliance.
• Provide QA oversight and approval for deviations, nonconformances (NCs), and validation exceptions related to NPS validation, implementation, and operation.
• Support CAPA activities associated with NPS by reviewing root cause analyses, corrective and preventive actions, and effectiveness checks to ensure sustainable compliance.
• Provide QA guidance and risk-based decision-making for NPS change control activities, including configuration changes, upgrades, patches, integrations, and infrastructure changes.
• Review and approve periodic reviews, user access reviews, data integrity assessments, and system health checks to ensure continued validated state and compliance.
• Participate in internal, vendor, and regulatory audits and inspections related to NPS systems, including preparation, audit support, response development, and follow-up actions.
• Provide guidance on system decommissioning activities, ensuring data retention, data integrity, and regulatory requirements are met.
• Drive continuous improvement initiatives to enhance CSA adoption, streamline NPS validation processes, reduce compliance burden, and improve efficiency.
• Contribute to the development, implementation, and maintenance of NPS-related quality procedures, work instructions, templates, and training materials.
• Mentor and coach stakeholders on CSA principles, risk-based validation, and Quality System expectations related to digital systems.

Benefits

• 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
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees