Director, Device Quality

Hims & Hers • Minnetonka, MN

21h

About The Position

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.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline (Master’s preferred)
• 10+ years of experience in medical device quality assurance, including leadership of regulated QMS environments. Sterilization experience preferred.
• Deep expertise in ISO 13485, FDA Quality System Regulation, EU MDR, and risk management principles
• Experience leading FDA inspections, ISO audits, and Notified Body audits
• Strong problem-solving skills with demonstrated success driving CAPA effectiveness and systemic improvements
• Executive-level communication skills and the ability to influence cross-functional stakeholders
• Experience working within an electronic Quality Management System (eQMS)

Responsibilities

• 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

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Director