Tech Professional, Quality Systems, AI
Relha LLC
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Job summary
Johnson & Johnson, DePuy Synthes, is seeking a Tech Professional in Raynham, MA to advance AI-enabled quality systems across the enterprise. You will provide day-to-day technical support for validated quality platforms and drive AI/automation improvements in a regulated MedTech environment.
The role requires 6+ years in quality tech, strong SQL and data analysis skills, and experience with QMS tools like Veeva Vault QMS or TrackWise. Travel up to 20% may be needed.
Qualifications
- Requires 6+ years of progressive experience supporting enterprise quality systems or quality technology in a MedTech/manufacturing environment.
- Hands-on experience with enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise, ETQ, Sparta) covering complaint handling, CAPA, nonconformance, and document control.
- Strong knowledge of GxP, 21 CFR Part 11, CSV, and data integrity (ALCOA+) requirements.
- Experience identifying and delivering automation or AI-enabled improvements within quality processes.
- Proficiency in SQL and data analysis to profile and interpret quality data across systems.
- Experience supporting validated system changes through formal change control, testing, and documentation.
- Experience with troubleshooting, root-cause analysis, and cross-functional collaboration.
- Proficiency with Python or similar scripting for automation and data workflows.
- Familiarity with Power BI/Tableau for quality metrics and dashboards.
- Preferred: MedTech/medical device domain and ISO 13485, EU MDR, FDA QSR/QMSR familiarity.
Responsibilities
- Provides day-to-day technical support for enterprise quality systems, troubleshooting issues and escalating as needed.
- Supports and enhances quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, and document management.
- Identifies and delivers AI and automation use cases across quality processes, including triage and document summarization.
- Partners with Data Science and AI teams to define data requirements and validate model outputs within quality workflows.
- Ensures AI/automation solutions meet GxP, 21 CFR Part 11, and ALCOA+ with proper validation and human-in-the-loop controls.
- Analyzes quality system data to identify trends and bottlenecks, recommending improvements.
- Supports computer system validation activities, including requirements, test scripts, and traceability.
- Builds dashboards and reporting to provide Quality leadership with system performance visibility.
- Collaborates with Quality process owners to gather requirements and support UAT and releases.
- Assesses implications of technology changes (ERP/PLM migrations) and defines requirements ahead of cutover.
Skills
Education
Tools
Job description
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
DePuy Synthes is recruiting for a Tech Professional, Quality Systems, AI, located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN.
The Tech Professional, Quality Systems, AI is a seasoned individual contributor within the Supply Chain Technology function, Quality sub-function, accountable for the support, enhancement, and AI-enabled modernization of the enterprise quality systems landscape at DePuy Synthes. Establishing methods based on proven research, this role provides day-to-day technical support and continuous improvement across validated quality platforms — including complaint handling, CAPA, nonconformance, document management, training, and audit systems — while identifying and delivering AI and automation opportunities that improve quality data insight, reduce manual effort, and accelerate cycle times. Applying advanced skills of the field, the role partners with Quality, Regulatory, Manufacturing, and Technology teams to ensure quality systems remain compliant, reliable, and increasingly intelligent in a regulated MedTech environment.
- Provides day-to-day technical support for enterprise quality systems, responding to and diagnosing issues through discussion with users, including troubleshooting, fault rectification, and problem escalation.
- Supports and enhances validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, document management, training records, and audit management.
- Identifies, evaluates, and delivers 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.
- Partners with Data Science and AI teams to define data requirements, validate model outputs, and operationalize AI-enabled capabilities within quality workflows.
- Ensures 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.
- Analyzes quality system data to identify trends, recurring issues, and process bottlenecks, and translates findings into system and process improvement recommendations.
- Supports computer system validation activities including requirements documentation, test script execution, traceability, and change control for quality platform changes.
- Builds and maintains reporting, dashboards, and metrics that provide Quality leadership with visibility into system performance, record aging, and compliance posture.
- Partners with Quality process owners to gather requirements, configure system enhancements, and support user acceptance testing and release activities.
- Assesses the quality systems implications of technology change — including platform migrations, ERP/PLM integrations, and separation/carve‑out activity — and defines requirements ahead of cutover.
- Required: Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related discipline.
- Preferred: Master's degree in Information Systems, Data Science, or Engineering.
- 6 years of progressive experience supporting enterprise quality systems, regulated business applications, or quality technology in a manufacturing or MedTech environment.
- Hands‑on experience with enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent) covering complaint, CAPA, nonconformance, and document control processes.
- Working knowledge of GxP, 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements.
- Demonstrated experience identifying and delivering automation or AI‑enabled improvements within business or quality processes.
- Strong SQL and data analysis skills, with the ability to profile and interpret quality data across systems.
- Experience supporting validated system changes through formal change control, testing, and documentation.
- Strong troubleshooting and root cause analysis skills for application, integration, and data issues.
- Effective communication skills, with the ability to work across Quality, Regulatory, Manufacturing, and Technology stakeholders.
- MedTech or medical device experience; familiarity with ISO 13485, EU MDR, and FDA QSR/QMSR requirements.
- Hands‑on experience applying Generative AI / LLM‑enabled tooling to complaint triage, document review, knowledge retrieval, or quality record summarization.
- Familiarity with machine learning concepts, model evaluation, and responsible AI controls in a regulated context.
- Experience integrating quality systems with ERP (SAP), PLM, and manufacturing execution systems.
- Proficiency with Python or a comparable scripting language for automation and data workflows.
- Experience with reporting and visualization tools (Power BI, Tableau) for quality metrics and executive dashboards.
- Experience supporting quality systems migration or stand‑up within a divestiture, carve‑out, or standalone entity.
- Exposure to intelligent automation platforms (RPA, workflow automation) applied to quality operations.
Travel: Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites.
Certifications: Lean/Six Sigma, ASQ CQE/CQA, ITIL v4 Foundation, or relevant quality systems platform certification preferred. AI/ML or cloud certifications (Azure AI Engineer, AWS Machine Learning) a plus.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
- Coaching
- Communication
- Continuous Improvement
- Critical Thinking
- Human-Computer Interaction (HCI)
- Industry Analysis
- Product Knowledge
- Product Lifecycle Management (PLM)
- Relationship Building
- Root Cause Analysis (RCA)
- Service Request Management
- Software Development Management
- Stakeholder Engagement
- System Administration
- Technical Credibility
- Technical Support
- Technologically Savvy
- Coaching
- Communication
- Collaboration
- Problem Solving
- Time Management
- Confidence
- Management
- Leadership
- Punctuality
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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