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About Mira

Mira, headquartered in San Francisco, is a pioneering hormonal health company serving over 300,000 customers with integrative care and hormone testing. Recognized as America’s fastest-growing femtech company in 2023, Mira leads the market with the only FDA-compliant at-home hormone monitor featuring quantitative testing technology. The company’s mission centers on making hormone data both accessible and insightful, empowering women to understand their health and make informed choices throughout various life stages including cycle health, family planning, hormone imbalances, and menopause.

Committed to enhancing health outcomes through personalized insights, advanced technology, and science-based data, Mira transforms hormone information into useful guidance for everyday wellness.

Role Overview

Mira seeks an experienced Quality Manager to establish and lead the company’s quality management system (QMS), ensuring adherence to regulatory standards such as FDA regulations and maintaining the company’s high standards of quality. The ideal candidate should possess expertise in implementing quality management processes, managing regulatory documentation, and developing quality control systems within the medical device or health product sectors. This role requires leadership capabilities to guide teams both domestically and in China.

Responsibilities

Lead and mentor quality teams across domestic and China operations.
Take ownership of the Quality Management System and drive continuous improvements.
Ensure compliance with regulatory standards including CE Mark and ISO certifications.
Proactively identify and implement quality enhancements with minimal supervision.
Coordinate with cross-functional teams across different regions to resolve quality issues.
Travel internationally, at least annually, to China to oversee overseas operations.
Act as the primary accountable leader for all quality and compliance matters, escalating issues proactively.

Requirements

At least 6 to 7 years of senior quality experience in the medical device industry, with direct responsibility for quality decisions.
Hands-on experience with CE Mark and ISO regulatory standards (including ISO 13485), having led or significantly contributed to audits or certifications.
Experience working in startups or agile environments, capable of independent judgment without extensive processes.
Willing and able to make international trips to China, occasionally on short notice.
Demonstrated strong ownership and proactive management style.
Detail-oriented, disciplined, and able to work calmly and professionally in demanding situations.
Proven ability to manage and coordinate stakeholders across multiple locations, including China, to resolve issues.
Preferred qualifications include experience with Health Canada or FDA regulations and managing geographically dispersed teams.

Benefits

Opportunity to work with a rapidly growing femtech leader committed to advancing women's health.
Collaborate with a motivated, international team passionate about making meaningful health impacts.
Fast-paced startup environment offering direct impact on company growth and strategy.
Career advancement potential with opportunities to build and lead expanding teams.
Flexible, fully remote work environment promoting autonomy and ownership.
Competitive compensation combined with performance bonuses linked to objectives and key results (OKRs).

Quality Manager (B2B, Remote)