ΠΡΠ° Π²Π°ΠΊΠ°Π½ΡΠΈΡ Π² Π°ΡΡ ΠΈΠ²Π΅
ΠΠΎΡΠΌΠΎΡΡΠ΅ΡΡ ΠΏΠΎΡ ΠΎΠΆΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ β7 Π΄Π½Π΅ΠΉ Π½Π°Π·Π°Π΄
Tech Professional, Quality Systems, AI
94Β 000 - 170Β 000$
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Tech Professional, Quality Systems, AI (MedTech/Quality Systems): Supporting and modernizing validated enterprise quality systems for complaint handling, CAPA, nonconformance, document management, training, and audits with an accent on AI-enabled automation, data analysis, and regulatory compliance. Focus on integrating AI into regulated quality workflows, validating models and system changes, and improving dashboards, traceability, and operational reliability.
Location: Hybrid role based in Raynham, MA, West Chester, PA, New Brunswick, NJ, Palm Beach Gardens, FL, or Warsaw, IN; up to 20% domestic travel required.
Salary: $94,000β$170,000 USD annually.
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions, with this role supporting DePuy Synthes quality technology operations.
What you will do
- Provide technical support, troubleshooting, fault resolution, escalation, and continuous improvement for validated enterprise quality systems.
- Support quality platforms covering complaints, CAPA, nonconformance, deviations, change control, document management, training, and audits.
- Identify and deliver AI and automation use cases such as complaint triage, adverse-event signal detection, document summarization, and intelligent search.
- Partner with Data Science, AI, Quality, Regulatory, Manufacturing, and Technology stakeholders to define requirements and operationalize AI capabilities.
- Maintain compliance with GxP, 21 CFR Part 11, ALCOA+, computer system validation, documented testing, traceability, and human-in-the-loop controls.
- Build reporting and dashboards, analyze quality data and bottlenecks, and support integrations, migrations, releases, and change-control activities.
Requirements
- Bachelorβs degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related discipline.
- At least 6 years of progressive experience supporting enterprise quality systems, regulated applications, or quality technology in manufacturing or MedTech.
- Hands-on experience with quality management systems such as Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent.
- Working knowledge of GxP, 21 CFR Part 11, computer system validation, data integrity, formal change control, testing, and documentation.
- Experience delivering automation or AI-enabled process improvements, with strong SQL, data analysis, troubleshooting, and root cause analysis skills.
- English proficiency and availability for up to 20% domestic travel are required.
Nice to have
- MedTech or medical device experience, including ISO 13485, EU MDR, and FDA QSR/QMSR familiarity.
- Experience with Generative AI, LLM tooling, machine learning concepts, model evaluation, and responsible AI controls.
- Experience with SAP, PLM, manufacturing execution system integrations, Python, Power BI, Tableau, RPA, or workflow automation.
- Experience with quality-system migrations, divestitures, carve-outs, or standalone entity implementations.
- Lean/Six Sigma, ASQ CQE/CQA, ITIL v4, quality platform, AI/ML, or cloud certifications.
Culture & Benefits
- Hybrid work arrangement within the listed United States locations.
- Retirement pension and 401(k) savings plans.
- Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, and volunteer leave.
- Inclusive workplace and reasonable accommodation support for applicants with disabilities.
- The role may transition to DePuy Synthes following the planned separation of the Orthopaedics business.