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 and 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.

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 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)

Our Benefits (there are more but here are some highlights):

• 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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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