Prof Quality Steward – Product Security

Johnson & Johnson Innovative Medicine•New Brunswick, NJ

7d•$81,000 - $131,100

About The Position

The Professional, Quality Steward is an individual contributor within Johnson & Johnson’s Product Security organization. The role provides quality stewardship and oversight of cybersecurity activities across the medical-device and connected-product lifecycle. It partners with Product Security, R&D, Systems Engineering, Software Engineering, Quality, and Regulatory Affairs to help ensure cybersecurity activities are planned, documented, reviewed, and maintained in accordance with the Quality Management System, 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 safe, secure, and compliant products. The position also supports postmarket cybersecurity and vulnerability management, regulatory submissions, audits, inspections, Product Security governance, and continuous improvement of related processes and materials. The role monitors evolving medical-device cybersecurity regulations and standards and helps translate requirements into practical Product Security and Quality System processes. The anticipated base pay range is $81,000–$131,100. Employees may be eligible for participation in the company’s pension and 401(k) savings plans and long-term incentive program, subject to plan terms. Listed time-off benefits include vacation, sick time, holiday pay, work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off, subject to applicable policies and eligibility.

Requirements

Bachelor’s degree in Engineering, Computer Science, Cybersecurity, Information Systems, Quality, Biomedical Engineering, or a related technical discipline.
At least 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.

Nice To Haves

Advanced degree.
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.

Responsibilities

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 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.

Benefits

Company consolidated retirement plan (pension)
401(k) savings plan
Long-term incentive program
Vacation: 120 hours per calendar year
Sick time: 40 hours per calendar year, with different stated amounts for employees residing in Colorado or Washington
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 a child’s birth, adoption, or foster care placement
Bereavement leave
Caregiver leave: 80 hours in a 52-week rolling period
Volunteer leave: 32 hours per calendar year
Military spouse time-off: 80 hours per calendar year