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 compliance  
• Lead continuous improvement initiatives that strengthen Quality System effectiveness, operational efficiency, and organizational compliance  
• Support regulatory submissions by providing Quality System documentation and Quality expertise as required  
• Build, lead, mentor, and develop Quality personnel, establishing clear expectations and promoting professional growth  
• Partner with Quality team members to ensure appropriate prioritization, ownership, and timely completion of Quality System activities  
• Foster a culture of quality and accountability across the broader organization by providing guidance, education, and leadership on Quality System expectations  
• Provide executive leadership with visibility into emerging quality risks, compliance trends, and recommendations for improvement  

Requirements: 

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related scientific or technical discipline  
• Minimum of 8 years of Quality Assurance or Quality Engineering experience within the medical device industry, including progressive leadership responsibility  
• Demonstrated experience leading Quality Systems and managing Quality personnel within a regulated medical device organization  
• Strong working knowledge of FDA Quality System requirements, ISO 13485, EU MDR, risk management principles, and medical device Quality System processes  
• Demonstrated experience serving as, or working closely with, the Management Representative for a medical device QMS  
• Experience leading or overseeing CAPA, nonconformances, complaints, change management, document control, training, supplier quality, risk management, and post-market processes  
• Demonstrated experience leading Management Reviews and communicating Quality System performance to executive leadership  
• Significant experience preparing for and supporting FDA inspections, ISO certification audits, notified body audits, and other regulatory or Quality System inspections  
• Experience managing supplier quality programs, including supplier qualification, monitoring, audits, quality agreements, and corrective actions  
• Experience providing Quality oversight for medical device product development, manufacturing, and post-market activities  
• Demonstrated ability to identify and resolve complex Quality System and compliance issues through effective cross-functional leadership  
• Strong understanding of Quality System metrics, trending, risk-based decision-making, and continuous improvement methodologies  
• Proven experience developing and mentoring Quality professionals and building high-performing teams  
• Excellent leadership, communication, organizational, and stakeholder management skills  
• Ability to effectively communicate Quality and compliance risks, recommendations, and priorities to executive leadership  
• Demonstrated ability to balance strategic leadership with hands-on execution in a fast-paced environment  

Preferred Qualifications: 

• Advanced degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline  
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certification  
• Experience serving as the formal QMS Management Representative  
• Experience within a startup or growth-stage medical device organization  
• Experience building, scaling, or significantly improving a medical device Quality Management System  
• Experience supporting connected, wearable, or electro-mechanical medical devices  
• Experience with FDA inspections and EU MDR/notified body audits  
• Experience working with contract manufacturers and external development or manufacturing partners  
• Experience leading Quality organizations through periods of significant commercial or organizational growth  

Compensation: 

• Base Pay: $210,000–$270,000 per year  
• Annual Bonus Eligibility