Director, Device Quality
Share
Job Location:
Minnetonka, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit 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. 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 Bachelors degree in Engineering Life Sciences or a related discipline (Masters 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) 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 youre excited about this role we encourage you to applyeven if youre 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 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. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: DirectorYou Will:
You Have:
Our Benefits (there are more but here are some highlights):
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
