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Johnson & Johnson

Makes prescription drugs and medical devices

Tech Professional - Quality Systems, AI

Enterprise ApplicationsPosted on Nov 11
Full-time

About the Job

Requirements

  • A bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related discipline is required.
  • At least 6 years of progressive experience supporting enterprise quality systems, regulated business applications, or quality technology in a manufacturing or MedTech environment is required.
  • Hands-on experience with enterprise quality management systems such as Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent, covering complaint, CAPA, nonconformance, and document control processes is required.
  • Working knowledge of GxP, 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements is required.
  • Demonstrated experience identifying and delivering automation or AI-enabled improvements within business or quality processes is required.
  • Strong SQL and data analysis skills, including the ability to profile and interpret quality data across systems, are required.
  • Experience supporting validated system changes through formal change control, testing, and documentation is required.
  • Strong troubleshooting and root cause analysis skills for application, integration, and data issues are required.
  • English proficiency is required.

Responsibilities

  • Provide day-to-day technical support for enterprise quality systems, responding to and diagnosing user issues through discussion, troubleshooting, fault rectification, and problem escalation.
  • Support and enhance validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, document management, training records, and audit management.
  • Identify, evaluate, and deliver AI and automation use cases across quality processes, including complaint triage and classification, adverse event signal detection, document summarization, and intelligent search across quality records.
  • Partner with Data Science and AI teams to define data requirements, validate model outputs, and operationalize AI-enabled capabilities within quality workflows.
  • Ensure AI and automation solutions applied to quality systems meet GxP, 21 CFR Part 11, and data integrity (ALCOA+) expectations, including documented validation and human-in-the-loop controls.
  • Analyze quality system data to identify trends, recurring issues, and process bottlenecks, and translate findings into system and process improvement recommendations.
  • Support computer system validation activities, including requirements documentation, test script execution, traceability, and change control for quality platform changes.
  • Build and maintain reporting, dashboards, and metrics that provide Quality leadership visibility into system performance, record aging, and compliance posture.
  • Partner with Quality process owners to gather requirements, configure system enhancements, and support user acceptance testing and release activities.
  • Assess quality systems implications of technology change, including platform migrations, ERP/PLM integrations, and separation or carve-out activity, and define requirements ahead of cutover.

Desired Qualifications

  • A master's degree in Information Systems, Data Science, or Engineering is preferred.
  • MedTech or medical device experience and familiarity with ISO 13485, EU MDR, and FDA QSR/QMSR requirements are preferred.
  • Hands-on experience applying Generative AI or LLM-enabled tooling to complaint triage, document review, knowledge retrieval, or quality record summarization is preferred.
  • Familiarity with machine learning concepts, model evaluation, and responsible AI controls in a regulated context is preferred.
  • Experience integrating quality systems with ERP (SAP), PLM, and manufacturing execution systems is preferred.
  • Proficiency with Python or a comparable scripting language for automation and data workflows is preferred.
  • Experience with reporting and visualization tools such as Power BI and Tableau for quality metrics and executive dashboards is preferred.
  • Experience supporting quality systems migration or stand-up within a divestiture, carve-out, or standalone entity is preferred.
  • Exposure to intelligent automation platforms, including RPA and workflow automation, applied to quality operations is preferred.
  • Lean/Six Sigma, ASQ CQE/CQA, ITIL v4 Foundation, relevant quality systems platform, AI/ML, or cloud certifications are preferred or a plus.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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