Director, Quality

Noctrix Health•Pleasanton, CA

10h•$210,000 - $270,000•Hybrid

About The Position

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.

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

Nice To Haves

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

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