Quality Director for Devices

Hims & Hers • Full-time • Minnetonka, Minnesota, United States • $130k - $150k / year • 2w ago

At Hims & Hers, we prioritize health and wellness, striving to provide personalized care that transforms lives. Our focus on innovative medical devices is integral to fulfilling our mission.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a closely related field; Master’s degree is preferred.
A minimum of 10 years in medical device quality assurance, with significant leadership experience in regulated environments.
In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and robust risk management practices.
Proven track record in leading FDA inspections, ISO audits, and Notified Body audits.
Strong analytical skills, particularly in driving CAPA effectiveness and systemic improvements.
Experience with electronic Quality Management Systems (eQMS).

Benefits

Competitive salary and equity options for full-time employees.
Unlimited paid time off, alongside company holidays and quarterly mental health days.
Comprehensive health plans, including medical, dental, and vision coverage.
Employee Stock Purchase Program (ESPP) for investment in your future.
401k with employer matching to help secure your retirement.
Opportunity to participate in team retreats focused on collaboration and connection.

You’ll Be a Great Fit If...

Your approach to quality transcends compliance; you see it as a core aspect of product development and user satisfaction. You thrive in environments where proactivity is valued, and you’re not afraid to voice concerns when standards slip. Your style of communication is clear and impactful, allowing you to influence stakeholders across diverse teams effortlessly. You’re skilled at translating regulatory complexities into actionable insights for your colleagues, promoting a culture of shared responsibility for quality. If you find fulfillment in mentoring others on the nuances of compliance and quality, you’ll not just fit in here—you’ll help elevate our entire operation. 🌱

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