Director, Quality Systems (63068)

Position Summary

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. The ideal candidate will bring deep expertise in ISO 13485, risk management, supplier quality, audits, and preferably MDSAP, with a strong track record of leadership and cross-functional collaboration.

Key Responsibilities

Quality Systems Oversight

• 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.

Quality Engineering Leadership

• 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.

Supplier Quality Management

• 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.

Risk Management & Compliance

• 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.

Leadership & Collaboration

• 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.

Minimum 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.
• Master's degree or advanced certification (e.g., ASQ CQE, CQA).
• Experience with MDSAP audit preparation and execution.
• Background in Class I and II medical devices and sustaining engineering.
• Experience supporting new product development quality activities.
• Familiarity with global regulatory requirements and standards.