Sr. Director - New Product Development Quality

Senior Director, NPD Systems Quality - New Product Development

The Senior Director of New Product Development Systems Quality  is a strategic leader responsible for designing, governing, and continuously improving products that enable innovation while ensuring compliance and product integrity across the entire development lifecycle. This role applies systems engineering principles-including requirements traceability, risk management, and robust verification and validation-to deliver consumer products that meet internal standards and global regulatory requirements from concept through commercialization.

Key Responsibilities

Strategic Leadership & Lifecycle Governance

• Define and execute the quality systems strategy for NPD, embedding systems thinking and lifecycle management into all phases.
• Lead governance for phase-gate reviews, ensuring requirements, risk mitigation, and compliance objectives are met.
• Serve as the primary quality interface between innovation, product development, engineering, manufacturing, and regulatory teams.

Systems Quality Framework

• Own and optimize NPD quality, including:
• Design Controls & Requirements Management
• Risk Analysis & Mitigation (e.g., DFMEA, hazard analysis)
• Change & Configuration Management
• Document Control & Traceability
• Verification & Validation Planning
• Supplier Quality Integration
• Establish metrics and dashboards to monitor quality performance and enable data-driven decisions.

Cross-Functional Integration

• Partner with R&D to ensure products are designed for quality, reliability, manufacturability, and compliance.
• Collaborate with Regulatory Affairs to meet global standards (FDA, ISO, EU MDR, etc.).
• Align with Operations and Supply Chain on supplier qualification and component reliability.

Compliance & Audit Readiness

• Maintain audit-ready processes aligned with ISO 9001, ISO 13485, GMP, and other applicable standards.
• Lead internal and external audits for NPD quality.

Leadership & Talent Development

• Build and mentor a high-performing team of quality professionals.
• Foster a culture of continuous improvement, accountability, and systems thinking across the organization.

Qualifications

• Education:
• Bachelor's degree in Engineering, Systems Engineering, or related field required.
• Advanced degree (MS, MBA, or PhD) preferred.
• Experience:
• 12+ years in quality assurance or systems engineering within regulated industries (consumer goods, medical devices, etc.).
• 5+ years in senior leadership roles driving cross-functional initiatives.
• Expertise in systems engineering principles, NPD lifecycle, and quality by design.
• Skills & Competencies:
• Strong leadership and change management capabilities.
• Proficiency in quality and systems tools (e.g., FMEA, Six Sigma, requirements management platforms).
• Experience with electronic Quality Management Systems (eQMS).
• Exceptional communication and stakeholder engagement skills.