Johnson & Johnson · 2 weeks ago
Sr Quality Engineer, NPS CSV
Santa Clara, California, United States of America
Full-time
Hybrid
Mid, Senior Level
$109K/yr - $175K/yr
6+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes through advanced treatments. The Senior Quality Engineer will oversee Quality Assurance for non-product software systems in GxP regulated environments, ensuring compliance and effective system management throughout the lifecycle.
Hospital & Health Care
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
Qualification
Required
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
Preferred
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
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase