Position Overview

We are seeking a strategic and experienced Director of Quality Management Systems (QMS) to lead and evolve our enterprise-wide quality systems. This individual will drive continuous improvement, ensure regulatory compliance, and support operational excellence across multiple manufacturing sites. The ideal candidate brings strong leadership capabilities, deep understanding of QMS frameworks (ISO 9001, ISO 13485, FDA, etc.), and a passion for embedding quality into every aspect of the organization.

Key Responsibilities:

• Develop, lead, and maintain the organization’s Quality Management System in alignment with regulatory and customer requirements.
• Own internal and external audit processes, including CAPA, root cause analysis, and risk management practices.
• Standardize and improve quality procedures across production, engineering, and supply chain operations.
• Ensure compliance with applicable standards and regulations (ISO, FDA, cGMP, etc.).
• Oversee document control, training systems, quality metrics, and management review processes.
• Partner with cross-functional leaders to identify and mitigate quality risks and drive process improvement initiatives.
• Manage quality certifications, recertifications, and regulatory inspections across all facilities.
• Lead and develop a high-performing quality systems team, fostering a culture of accountability and excellence.
• Serve as the quality systems subject matter expert during audits, customer visits, and regulatory inquiries.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
• 10+ years of quality systems experience in manufacturing, medical device, pharma, or a similarly regulated industry.
• 5+ years in a senior leadership role overseeing QMS at a multi-site or global level.
• Deep knowledge of QMS principles and standards: ISO 9001, ISO 13485, FDA QSR, IATF 16949, or related.
• Exceptional leadership, project management, and change management skills.
• Strong analytical and communication skills with a hands-on, collaborative approach.

Preferred Systems Experience:

• TrackWise, MasterControl, SAP, EtQ, or equivalent QMS platforms.