Prof Quality Steward – Product Security

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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 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.

Key Responsibilities

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* 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 cybersec...