Director, Quality Systems

About the Role

We are seeking a strategic and hands-on Director of Quality Systems and Quality Engineering to lead and evolve our quality systems and engineering functions. This role will maintain the quality management system, oversee sustaining engineering for Class I medical devices primarily marketed in the U.S., support new product development initiatives, and manage our electronic Quality Management System (eQMS), ComplianceQuest.

Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations.
• Oversee the administration and optimization of the eQMS platform (ComplianceQuest), ensuring system integrity, user adoption, and compliance.
• Ensure readiness and lead external audits, including customer, FDA, and Notified Body.
• Conduct quality due diligence for Mergers & Acquisitions.
• Manage a team of quality engineers supporting sustaining activities for Class I and II medical devices.
• Provide quality engineering support for new product development, including design control, risk management (ISO 14971), and verification/validation activities.
• Drive root cause analysis and corrective/preventive actions (CAPA) for product and process issues.
• Develop and maintain robust supplier quality processes including qualification, monitoring, and auditing.
• Collaborate with Sourcing and Operations to ensure supplier compliance and performance.
• Ensure supplier audits are performed and support resolution of supplier-related quality issues.
• Champion risk-based thinking across the organization, ensuring effective risk management practices are embedded in product lifecycle processes.
• Ensure QMS alignment with applicable standards and regulations.
• Build and mentor a high-performing quality team, fostering a culture of accountability, continuous improvement, and collaboration.
• Partner cross-functionally with R&D, Operations, Regulatory, and Sourcing to ensure quality objectives are met.
• Represent Quality in strategic planning and business reviews.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in medical device quality, with at least 5 years in a leadership role.
• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and supplier quality.
• Experience with internal and supplier audits.
• Proficiency with electronic QMS platforms; ComplianceQuest experience is a plus.
• Demonstrated ability to lead teams and drive cross-functional collaboration.
• Excellent communication, leadership, strategic thinking, and problem-solving skills.