Sr. Director Systems Quality 

We are seeking a visionary and experienced Senior Director of Systems Quality to lead our enterprise-wide quality strategy across multiple product categories. This role is critical to building and sustaining a high-performing Quality Management System (QMS) that supports innovation at scale—without compromising reliability, compliance, or customer trust.

As a strategic leader, you will direct systems-level quality initiatives, evolve our QMS framework, and foster cross-functional alignment between engineering, testing, and manufacturing. Your leadership will ensure quality is embedded into every phase of our product lifecycle, from concept to customer use.

Key Responsibilities

• Define and lead the systems-level quality strategy across all product categories, ensuring alignment with enterprise goals and customer expectations.

• Own and evolve the Quality Management System (QMS), including document control, change management, CAPA, product and supplier quality, risk management, and technological infrastructure.

• Drive cross-functional collaboration with Engineering, R&D, Manufacturing, and Compliance to ensure end-to-end quality ownership and operational excellence.

• Establish and oversee robust validation protocols, testing strategies, and continuous improvement initiatives to elevate product reliability and safety.

• Ensure compliance with global quality and regulatory standards (e.g., ISO, FDA, EU MDR), internal policies, and customer-specific requirements.

• Lead and develop a high-performing team of quality engineers and managers, instilling a culture of accountability, innovation, and data-driven decision-making.

• Embed quality into all stages of product development, from early design reviews to post-market surveillance, enabling faster and safer time-to-market.

• Provide the systems, tools, and metrics that empower teams to innovate rapidly while maintaining rigorous quality and compliance standards.

• Drive organizational excellence by shaping how teams think about, measure, and improve quality at scale, using data to inform strategy and decision-making.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Quality, Regulatory, or a related technical field.

• 10+ years of progressive experience in quality systems and leadership roles within consumer goods, medical devices, or similar regulated industries.

• Deep knowledge of quality standards and regulations (e.g., ISO 9001/13485, FDA QSR, EU MDR, Six Sigma).

• Proven success managing enterprise-level QMS and scaling quality infrastructure to support innovation and growth.

• Exceptional cross-functional leadership and communication skills, with experience influencing at all levels of the organization.

• Track record of building and leading high-performing teams in dynamic, fast-paced environments.

• Strong analytical and systems-thinking approach to quality improvement, risk mitigation, and change management.