Director, Quality

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and strategic Director, Quality to lead the maintenance, effectiveness, and continuous improvement of Noctrix Health’s Quality Management System (QMS). This leader will provide oversight of quality processes supporting product development, manufacturing, supplier quality, post-market activities, and regulatory compliance throughout the product lifecycle. The Director, Quality will serve as the Management Representative for the Quality Management System and will be accountable for QMS performance, inspection and audit readiness, supplier quality oversight, and the effective execution of quality processes across the organization. Working closely with Regulatory Affairs, Clinical Affairs, Engineering, Operations, Manufacturing, and external partners, this individual will provide both strategic leadership and hands-on guidance while fostering a culture of quality, accountability, and continuous improvement. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Lead the maintenance, effectiveness, and continuous improvement of Noctrix Health’s Quality Management System in accordance with FDA requirements, ISO 13485, EU MDR, and other applicable regulations and standards Serve as the QMS Management Representative and regularly report Quality System performance, compliance status, key risks, and improvement initiatives to executive leadership Provide leadership and oversight across core Quality System processes, including CAPA, nonconformances, complaints, change management, document control, training, risk management, supplier quality, and post-market surveillance Lead Management Review activities, including preparation, execution, documentation, presentation of Quality System performance, and follow-up of resulting actions Establish, monitor, and continuously improve quality metrics, KPIs, and trend reporting to evaluate QMS effectiveness and identify areas requiring action Develop and maintain a comprehensive audit and inspection-readiness strategy across the organization Plan, conduct, and oversee internal audits, supplier audits, certification audits, and regulatory inspections Serve as a key Quality leader during regulatory inspections and interactions with notified bodies, certification bodies, and regulatory authorities Ensure timely and effective resolution of audit observations, inspection findings, corrective actions, and other Quality System commitments Oversee supplier quality activities, including supplier qualification, risk assessment, performance monitoring, audits, quality agreements, and supplier corrective actions Partner with Engineering, Operations, Manufacturing, Regulatory Affairs, and other functions to ensure appropriate Quality oversight throughout product development, design changes, manufacturing activities, and commercialization Provide Quality leadership and guidance for risk management, Design Control, manufacturing changes, and post-market activities Serve as the primary escalation point for complex product quality, Quality System, and compliance issues and facilitate effective cross-functional resolution Identify barriers to Quality System execution and provide the leadership, resources, and hands-on support necessary to resolve issues and maintain complia…