Job Function: Technology Product & Platform Management
Job Sub Function: Technology Operations Support
Job Category:Scientific/Technology
All Job Posting Locations:Raynham, Massachusetts, United States of America
Job Description: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.
Key Responsibilities
- 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.
Qualifications
Education
- 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.
Experience and Skills
Required
- 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.
Preferred
- 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.
Other
- Travel: Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites.
- Language: English proficiency required.
- 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.
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#DePuySynthesCareers
Required Skills:Preferred Skills: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
The anticipated base pay range for this position is :94,000.00 - 170,000.00 USD
Additional Description for Pay Transparency:
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
