Director, Quality Engineering-Software and Product Security
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Job Description
Job Summary
The Director, Quality Engineering – Software & Product Security is responsible for leading the integrated software quality and product security strategy for the platform. This role serves as a key member of the Quality Engineering and R&D leadership teams, driving excellence in design controls, risk management, verification and validation, secure software development, cybersecurity maturity, and regulatory compliance.
The Director partners closely with R&D, Product Security, Enterprise Security, Regulatory Affairs, Legal, PMO, and business leadership to ensure the delivery of high quality, compliant, and secure software-enabled products across the entire product lifecycle.
This leader will build and develop strong engineering teams, lead strategic improvement initiatives, and ensure BD products meet both regulatory expectations and customer needs.
Primary Responsibilities
Leadership & Strategy
Define and drive the integrated strategy for software quality engineering and product security across innovation, new product development, sustaining engineering, and end-of-support planning.
Serve as a member of applicable leadership teams, contributing to long-term platform strategy, portfolio planning, and resource alignment.
Build and sustain a culture of quality, security, compliance, agility, and innovation across the development organization.
Quality Engineering Responsibilities
Lead the development, implementation, and maintenance of robust Quality Engineering programs, including design controls, software verification/validation, risk management, and compliance with global regulatory requirements.
Oversee software quality engineering deliverables for design reviews, audits, FDA and Notified Body inspections, and regulatory submissions.
Align software validation and lifecycle processes across BD to ensure consistent and efficient execution.
Manage quality metrics and present performance trends during management reviews.
Identify and drive continuous improvement within the Quality Management System (QMS) to enhance compliance and product quality.
Product Security Responsibilities
Provide technical and strategic leadership for secure architecture, threat modeling, vulnerability assessments, penetration testing, and incident response activities.
Lead adoption of enterprise product security frameworks in alignment with global regulations and corporate standards.
Drive cybersecurity maturity improvements across the platform including automated security testing, secure SDLC practices, and supplychain security.
Partner with R&D engineering teams to integrate security requirements and ensure secure product design, development, and risk mitigation over the lifecycle.
Cross-Functional Collaboration
Build strong, collaborative relationships
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