New · posted Nov 11
Johnson & Johnson · Medical Devices
Tech Professional, Quality Systems, AI
- Raynham, MA
- Hybrid
- Full-time
- Senior & Principal
The role
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.
What you need
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.
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.
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 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.
Preferred Skillsnice to have
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
What you'll do
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.
Pay and benefits
$96,000 – $155,250 a year
Employer providedThe anticipated base pay range for this position is
$96,000.00 - $155,250.00
401(k) savings plan and pension
Long-term incentive program
Vacation 120 hours per year
Sick time
13 paid holidays
Parental leave
Where you'll work
Raynham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Raynham, MAWorking conditions
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
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
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)).
This position is eligible to participate in the Company’s long-term incentive program.
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
Additional information can be found through the link below.
Co-Ops and Intern Positions: Please use the following language:
Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.
Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.
Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).
Positions Represented by CBA: Please use the following language:
This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts5 roles publishing pay
Senior & Principal roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $96,000 | — | $155,250 |
| Massachusetts (middle half) | $117,000 | $125,500 | $125,500 |
| All US (middle half) | $106,500 | $117,000 | $126,250 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 96 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk17
- Data and digital systems10
- Documentation and SOPs9
- Investigations and CAPA7
- Validation and qualification7
- Collaboration and leadership6
- GMP and compliance5
- Lab testing and methods4
- Regulatory submissions1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the five this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 18
- Locations
By discipline
- Quality25 60%
- Clinical9 21%
- Regulatory8 19%
By level
- Manager16 38%
- Senior & Principal15 36%
- Associate & Specialist7 17%
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Tech Professional, Quality Systems, AI at Johnson & Johnson
Applications close November 17. $96K–$155K a year, employer provided.