Director, Device Quality

Director, Device Quality Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.  Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. ABOUT THE ROLE: We are seeking a Director, Device Quality to lead and evolve the medical device Quality Management System (QMS) at Hims and Hers. Reporting to the SVP, Quality, this role owns the strategy, execution, and continuous improvement of our medical device quality systems to ensure compliance with global regulatory requirements and industry standards. This leader will serve as both the Person Responsible for Regulatory Compliance (PRRC) under EU MDR and the ISO 13485 Management Representative for YourBio Health, a subsidiary of Hims and Hers. You will be accountable for ensuring product conformity, regulatory compliance, post-market oversight, and executive visibility into QMS performance. This is a high-impact role requiring strong regulatory expertise, operational rigor, and the ability to build a proactive quality culture across a growing organization. YOU WILL: Lead and Strengthen the Quality Management System - Own the development, implementation, and continuous improvement of the QMS in alignment with ISO 13485, FDA QSR, EU MDR, and other applicable regulations - Serve as Management Representative, ensuring the QMS is effective and reporting performance, risks, and improvement initiatives to executive leadership - Maintain oversight of document control, training, validation activities, test method validation, calibration, and quality records within the eQMS - Drive audit readiness and lead interactions with FDA, ISO registrars, and Notified Bodies Serve as PRRC and Ensure Regulatory Compliance - Verify product conformity prior to release - Oversee technical documentation, product labeling, Declarations of Conformity, and post-market surveillance activities - Ensure vigilance reporting and corrective actions are implemented effectively - Monitor evolving regulatory requirements and proactively guide the organization through changes Own Core Quality Processes - Lead CAPA, nonconformance, complaint handling, change control, and risk management programs - Drive thorough root cause investigations and ensure corrective actions are effective and sustainable - Oversee supplier quality management, including qualification and ongoing performance monitoring - Identify systemic risks and implement continuous improvement initiatives across the organization Champion a Culture of Quality - Partner with R&D, Operations, Regulatory, and Clinical teams to embed quality throughout the product lifecycle - Provide training and guidance to strengthen regulatory awareness and compliance accountability - Escalate significant compliance risks when appropriate and exercise authority to pause product release or distribution if quality standards are not met - Advocate for the voice of the customer by ensuring product quality, safety, and performance consistently meet user needs and expectations YOU HAVE: - Bachelor’s degree in Engineering, Life Sciences, or a related discipline (Master’s preferred) - 10+ years of ex ... (truncated, view full listing at source)