Tech Professional, Quality Systems, AI

Biopharma Careers; Raynham (MA); On-site; USD 94,000 - 170,000; Full time

Job summary

Johnson & Johnson’s DePuy Synthes division seeks a Tech Professional, Quality Systems, AI to support AI-enabled modernization of enterprise quality systems. You will ensure regulatory compliance (GxP, 21 CFR Part 11) while driving automation across complaint handling, CAPA, nonconformance, and document management.

Based in Raynham, MA, this role partners with Quality, Regulatory, Manufacturing, and Technology teams to deliver intelligent quality workflows and insightful dashboards.

Qualifications

• 6 years of progressive experience supporting enterprise quality systems.
• Hands-on experience with enterprise quality management systems.
• Working knowledge of GxP, 21 CFR Part 11, data integrity (ALCOA+).
• Demonstrated ability delivering automation or AI-enabled improvements.
• Strong SQL and data analysis skills for quality data.
• Experience with validated system changes, testing, and documentation.

Responsibilities

• Provides day-to-day technical support for enterprise quality systems.
• Supports and enhances quality platforms covering complaint handling, CAPA, nonconformance, and document control.
• Identifies and delivers AI and automation use cases across quality processes.
• Partners with Data Science and AI teams to define data requirements and validate models.
• Ensures AI solutions comply with GxP, 21 CFR Part 11, and ALCOA+ data integrity.
• Analyzes quality system data to identify trends and improvement opportunities.
• Supports computer system validation activities including requirements, tests, and change control.
• Builds reporting, dashboards, and metrics for Quality leadership.
• Collaborates with Quality process owners to configure enhancements and support UAT.

Skills

SQL

Data analysis

Python

AI/ML

Quality systems knowledge

Troubleshooting

Education

Bachelor's degree in Computer Science

Master's degree in Information Systems

Tools

Veeva Vault QMS

TrackWise

ETQ

SAP ERP

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.

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, ora relateddiscipline.

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) coveringcomplaint , CAPA, nonconformance, and document control processes.
• Working knowledge ofGxP , 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements.
• Demonstrated experienceidentifyingand 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.
• Proficiencywith 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: Englishproficiencyrequired.

Certifications:Lean / S ix Sig ma,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,careerand 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 & Johnsonisan 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,stateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that isinclusive ofour applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contactAskGSto be directed to your accommodation resource.

Pay Transparency

The anticipated base pay range for this position is :

94,000.00 - 170,000.00 USD

Additional Description for Pay Transparency

• 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