Sr Quality Engineer, NPS CSV

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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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 & 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.

Job 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.
  

Qualifications:

• 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 usebased 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.

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The anticipated base pay range for this position is :

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Senior IC