Prof Quality Steward - Product Security

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

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

Job Description:

Job Overview

The Professional Quality Steward is an individual contributor within theProduct Security organizationresponsible 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 arecomplete consistent traceable and inspection-ready supporting the development and maintenance of safe secure and compliant products.

Key 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 Securityacross 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 riskthroughout 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.

Qualifications

Education

• B achelors 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.

Preferred

• Medical device MedTech digital health or other regulated-product experience
• Knowledge of FDA medical-device cybersecurity expectations ISO 14971 ISO 13485 IEC 62304 IECand 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 CISApreferred.

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

$81000.00 - $131100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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 Companys 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: ]]><