Director, Device Quality

Hims & Hers

Any Location, MN

Category Information Technology

Job Description

Hims & Hers is seeking a Director, Device Quality to lead and evolve the medical device Quality Management System (QMS) to ensure compliance with global regulatory requirements and industry standards. This high-impact role requires strong regulatory expertise, operational rigor, and the ability to build a proactive quality culture across a growing organization.

Requirements

Lead and Strengthen the Quality Management System
Serve as Management Representative, ensuring the QMS is effective and reporting performance, risks, and improvement initiatives to executive leadership
Drive audit readiness and lead interactions with FDA, ISO registrars, and Notified Bodies
Verify product conformity prior to release
Oversee technical documentation, product labeling, Declarations of Conformity, and post-market surveillance activities
Own Core Quality Processes
Champion a Culture of Quality

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

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