Quality Manager (Remote, B2B)

About the role

MiraMira is seeking a senior Quality Manager to build and lead its Quality Management System, ensuring products and processes meet FDA, CE Mark, ISO and other regulatory standards. The role is fully remote, supporting both domestic and China‑based operations.

Key responsibilities

• Lead and develop quality team members across U.S. and China operations.
• Own and continuously improve the organization’s Quality Management System (QMS).
• Maintain compliance with CE Mark, ISO 13485 and other applicable regulations.
• Identify, propose, and drive quality initiatives and process improvements.
• Coordinate cross‑functional and cross‑geography stakeholders to resolve open issues.
• Travel to China at least once a year to oversee overseas operations.
• Serve as primary accountability for quality and compliance matters, escalating proactively.

Required profile

• 6‑7+ years in the medical device industry in a senior quality role with direct decision‑making authority.
• Hands‑on experience with CE Mark and ISO 13485 regulatory frameworks, including audit or certification leadership.
• Experience in a fast‑moving startup environment, comfortable making judgment calls.
• Willingness to travel internationally to China on short notice.
• Strong ownership mindset and ability to manage upwards proactively.
• Disciplined, detail‑oriented, low‑drama work approach.

Required skills

• CE Mark compliance
• ISO 13485 implementation
• FDA regulatory knowledge
• Health Canada regulatory experience (preferred)
• Quality Management System development

What we offer

• Competitive salary with performance‑based bonus tied to OKRs.
• Fully remote work environment supporting autonomy and ownership.
• Opportunity to shape and build teams as the company scales.
• Impactful work in a fast‑growing femtech startup improving women’s health.
• International, passionate team and fast‑paced startup culture.