About The Position

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.

Requirements

  • Bachelor’s degree in Engineering, Systems Engineering, or related field required.
  • Advanced degree (MS, MBA, or PhD) preferred.
  • 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.

Nice To Haves

  • 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.

Responsibilities

  • 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.
  • Own and optimize NPD quality, including Design Controls & Requirements Management, Risk Analysis & Mitigation, Change & Configuration Management, Document Control & Traceability, Verification & Validation Planning, and Supplier Quality Integration.
  • Establish metrics and dashboards to monitor quality performance and enable data-driven decisions.
  • 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.
  • Maintain audit-ready processes aligned with ISO 9001, ISO 13485, GMP, and other applicable standards.
  • Lead internal and external audits for NPD quality.
  • Build and mentor a high-performing team of quality professionals.
  • Foster a culture of continuous improvement, accountability, and systems thinking across the organization.

Benefits

  • Competitive health insurance
  • Retirement plans
  • Paid time off
  • Employee stock purchase options
  • Wellness programs
  • SharkNinja product discounts
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