# Senior Quality Engineer. QMS at Johnson & Johnson

Johnson & Johnson is hiring a Senior Quality Engineer. QMS in Athens, United States. It pays $79k-$128k a year and Level rates it Little AI ●○○○; you can [apply on Johnson & Johnson](https://jobsbylevel.com/go/4634fa9c-310b-498b-b1b9-a8318c422d3a?utm_medium=ai-agent).

AI Level 1, AI centrality 37 out of 100. Athens, Georgia, United States of America.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 37 out of 100)
- Location: Athens, Georgia, United States of America
- Salary: $79k-$128k
- Posted: October 21, 2026
- Apply: https://jobsbylevel.com/go/4634fa9c-310b-498b-b1b9-a8318c422d3a?utm_medium=ai-agent

## Description

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Athens, Georgia, United States of America Job Description: The Senior Quality Engineer provides technical quality leadership for computerized systems, equipment, and digital solutions used within a regulated environment. This role is responsible for developing and executing Computerized System Validation (CSV) strategies, applying risk-based approaches to qualification and validation, providing quality guidance with change management, and ensuring systems and processes maintain appropriate data integrity throughout their lifecycle. The Senior Quality Systems Engineer partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure that systems are fit for intended use, appropriately controlled, and maintained in a validated state. The position serves as a subject matter expert and provides practical, risk-based guidance that balances compliance requirements, patient/product risk, and operational needs Key Responsibilities Support qualification and validation activities for equipment, systems, including computerized systems used in regulated business and manufacturing processes. Apply a risk-based approach to determine the appropriate scope and rigor of qualification and validation activities. Review and approve lifecycle documentation such as validation plans, user requirements, functional and configuration specifications, risk assessments, test protocols/scripts, traceability documentation, validation reports, and system retirement documentation. Provide change management direction and guidance on appropriate validation strategies based on intended use, system complexity, regulatory impact, and risk. Provide quality oversight for implementation, upgrades, configuration changes, integrations, migrations and retirement of computerized systems. Support investigation and resolution of validation discrepancies, test failures, and system-related quality issues. Ensure validated systems remain in a controlled state throughout their operational lifecycle. Facilitate and/or participate in system, process, and functional risk assessments. Use risk assessments to focus verification activities on functions that have the greatest potential impact on product quality, patient safety, data integrity, or regulatory compliance. Support qualification strategies for equipment, infrastructure, automation, and computerized systems, as applicable. Serve as a technical quality resource for data integrity assessments and remediation activities. Evaluate systems and processes for controls supporting ALCOA+ data integrity principles. Assess areas such as user access, roles and permissions, audit trails, electronic records, electronic signatures, data retention, backup/recovery, interfaces, and data lifecycle controls. Participate in periodic reviews and assessments of computerized systems to verify that systems remain fit for intended use and appropriately controlled. Support investigations involving suspected data-integrity issues and assist in determining appropriate corrective and

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/senior-quality-engineer-qms-at-johnson-johnson-f422dc

Source: https://jobsbylevel.com/jobs/senior-quality-engineer-qms-at-johnson-johnson-f422dc

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