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About Mira
Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company.
Mira’s breakthrough innovation was creating the market’s only FDA-compliant at-home hormone monitor with quantitative testing technology. From the beginning, our mission has been to make hormone data accessible and meaningful - so women can understand their bodies and make confident health decisions at every stage of life, from cycle health and family planning to hormonal imbalances and the menopause transition.
We are committed to improving real health outcomes through personalized insights, cutting-edge technology, and science-backed data—turning hormone information into practical guidance for everyday wellbeing.
About The Position
We are looking for a Quality Manager to build and lead our quality management system, ensuring our products and processes meet regulatory requirements (including FDA standards) and the company's high quality bar. The ideal candidate has experience implementing quality management systems, handling regulatory documentation, and building quality control processes at medical device or health product companies.
If you want to challenge yourself at a high-growth startup and make a difference for women's health, please join us!
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Benefits
- Join one of the fastest-growing femtech companies in the U.S., driven by a strong mission to advance women’s health and expand access to care
- Be part of a passionate, highly motivated, and international team dedicated to making a real difference in people’s lives
- Thrive in a fast-paced startup environment where your work directly impacts company growth, strategy, and key decisions
- Enjoy real opportunities for career growth, with the ability to shape, build, and develop teams as we scale
- Work in a flexible, fully remote environment that supports autonomy, ownership, and independence
- Receive a competitive salary along with a performance-based bonus system tied to OKRs
Responsibilities
- Lead and develop quality team members across both our domestic and China-based operations
- Own and continuously improve the Quality Management System (QMS) for the entire organization
- Ensure ongoing compliance with CE Mark, ISO, and other applicable regulatory requirements
- Identify, propose, and drive quality initiatives and process improvements with minimal oversight
- Coordinate cross-functional and cross-geography stakeholders to bring open issues to resolution
- Travel internationally to China at least once a year to oversee overseas operations in person
- Serve as the primary point of accountability for quality and compliance matters, escalating proactively rather than waiting to be asked
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Requirements
- 6-7+ years of experience in the medical device industry, in a senior quality role, including direct ownership of quality decisions with real consequences (not just supporting involvement).
- Direct, hands-on experience with CE Mark and ISO regulatory frameworks (e.g., ISO 13485), including leading or being a key contributor on an audit or certification.
- Prior experience at a startup or small, fast-moving company — comfortable making judgment calls without the process and resources of a large enterprise.
- Willingness and ability to travel internationally to China at least once a year, sometimes on short notice.
- A strong sense of ownership, with a track record of proactively managing upwards rather than waiting for direction.
- A disciplined, detail-oriented, low-drama approach to your work.
- Demonstrated ability to organize stakeholders across teams and geographies (including China) and drive issues to resolution independently.
Preferred:
- Health Canada or FDA regulatory experience, and experience managing teams across multiple geographies.
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