New · posted Nov 4
Johnson & Johnson · Medical Devices
Prof Quality Steward – Product Security
- New Brunswick, NJ +1 more
- On-site
- Full-time
- Senior & Principal
The role
The Professional, Quality Steward is an individual contributor within the Product Security organization responsible for providing quality stewardship and oversight of cybersecurity activities across the medical device and connected-product lifecycle.
This role partners with Product Security, R&D, Systems Engineering, Software Engineering, Quality, and Regulatory Affairs to ensure cybersecurity activities are appropriately planned, documented, reviewed, and maintained in accordance with the Quality Management System (QMS), design controls, regulatory requirements, and Product Security processes.
The Quality Steward helps ensure cybersecurity deliverables and objective evidence are complete, consistent, traceable, and inspection-ready, supporting the development and maintenance of safe, secure, and compliant products.
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.
What you need
Education
- Bachelor’s degree in Engineering, Computer Science, Cybersecurity, Information Systems, Quality, Biomedical Engineering, or a related technical discipline.
- Advanced degree preferred.
Required Experience and Skills
- 4+ years of experience in medical-device Quality, software quality, design assurance, product security, cybersecurity compliance, systems engineering, or a related regulated product-development discipline.
- Experience with design controls, risk management, verification and validation, change control, and Quality Management Systems.
- Working knowledge of cybersecurity concepts including threat modeling, cybersecurity risk management, vulnerability management, security testing, and SBOMs.
- Experience reviewing technical documentation and objective evidence for completeness, traceability, and compliance.
- Strong communication and cross-functional collaboration skills.
Preferrednice to have
- Medical device, MedTech, digital health, or other regulated-product experience
- Knowledge of FDA medical-device cybersecurity expectations, ISO 14971, ISO 13485, IEC 62304, IEC 81001-5-1, and AAMI TIR57/TIR97.
- Experience reviewing cybersecurity deliverables such as threat models, cybersecurity risk assessments, security requirements, penetration-test reports, SBOMs, and vulnerability assessments.
- Experience supporting regulatory submissions, audits, inspections, or postmarket cybersecurity activities.
- Relevant certifications such as CQE, CSQE, RAC, CSSLP, CISSP, or CISA preferred.
Preferred Skillsnice to have
AI Judgement Integration, Business Behavior, Compliance Management, Critical Thinking, Cybersecurity, Fraud Management, Legal Services, Problem Solving, Process Oriented, Risk Assessments, Security Architecture Design, Security Incident Response, Security Policies, Situational Awareness, Standard Operating Procedure (SOP), Technical Credibility, Technology Quotient, Training Delivery Methods
What you'll do
- Provide quality and compliance guidance for cybersecurity activities, including security planning, threat modeling, cybersecurity risk assessments, security requirements, testing, SBOMs, and vulnerability management.
- Serve as the Quality Steward for Product Security across assigned products, platforms, and programs throughout the product lifecycle.
- Review Product Security deliverables and objective evidence for completeness, traceability, consistency, and alignment with established QMS and cybersecurity processes.
- Ensure cybersecurity activities are appropriately integrated into design controls, product risk management, Design History Files, and lifecycle processes.
- Partner with Product Security, R&D, Quality, and Regulatory Affairs to identify and resolve cybersecurity documentation, process, and compliance gaps.
- Support cybersecurity content and evidence for regulatory submissions, audits, inspections, and responses to regulatory authorities.
- Provide quality stewardship for postmarket cybersecurity and vulnerability management, including risk assessments, remediation documentation, product changes, and coordinated vulnerability disclosure activities.
- Support governance of SBOMs and third-party/open-source software cybersecurity risk throughout the product lifecycle.
- Assess Product Security quality impacts associated with product changes, software releases, supplier changes, platform migrations, and lifecycle transitions.
- Support development and continuous improvement of Product Security procedures, work instructions, templates, metrics, and training.
- Monitor evolving medical-device cybersecurity regulations and standards and help translate requirements into practical Product Security and Quality System processes.
Pay and benefits
$81,000 – $131,100 a year
Employer providedThe anticipated base pay range for this position is
$81,000.00 - $131,100.00
Pension and 401(k) savings plan
Long-term incentive program
Vacation (120 hours per year)
Sick time
13 paid holidays
Parental leave
Where you'll work
New Brunswick, NJ +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: West Chester, PA
More jobs in New Brunswick, NJ +1 moreWorking conditions
Job Function
Legal & Compliance
Job Sub Function
Product Security
Job Category
Professional
All Job Posting Locations
New Brunswick, New Jersey, United States of America, West Chester, Pennsylvania, 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
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US48 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $81,000 | — | $131,100 |
| All US (middle half) | $115,250 | $128,000 | $133,625 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 73 open Design Quality & Assurance 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 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk13
- GMP and compliance9
- Documentation and SOPs7
- Data and digital systems5
- Lab testing and methods4
- Collaboration and leadership3
- Regulatory submissions2
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device softwareNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 37
- Open roles
- 37
- Distinct roles
- 17
- Locations
By discipline
- Quality16 43%
- Clinical12 32%
- Regulatory9 24%
By level
- Manager11 30%
- Senior & Principal11 30%
- Associate & Specialist8 22%
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Prof Quality Steward – Product Security at Johnson & Johnson
Applications close November 12. $81K–$131K a year, employer provided.