Mira
Quality Systems Specialist (Remote EU, Contractor Agreement)
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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
The Quality Systems Specialist is responsible for maintaining the Quality Management System (QMS), conducting product compliance reviews, training personnel on Standard Operating Procedures (SOPs), and ensuring daily adherence to quality system requirements. This role will also facilitate design review checklists in collaboration with the R&D team to support product development and regulatory compliance. Additionally, the specialist will support audits and compliance with FDA, Health Canada, the Therapeutic Goods Administration (TGA), and Medical Device Single Audit Program (MDSAP) requirements.
If you want to challenge yourself at a high-growth startup and make a difference for women's health, please join us!
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or a related field.
- Minimum 3+ years of hands-on experience in Quality Assurance, Quality Systems, or Regulatory Compliance within the IVD or Medical Device industry.
- In-depth understanding of ISO 13485, FDA 21 CFR Part 820 (QSR), Health Canada Medical Device Regulations (CMDR), TGA requirements, and the MDSAP framework.
- Experience with QMS software, document control systems, audit processes, CAPA management, and supplier quality oversight.
- Auditing & Supplier Management: Experience conducting internal/external audits, working with notified bodies, and ensuring supplier compliance (including overseas contract manufacturers).
- Ability to manage multiple quality initiatives, analyze data for continuous improvement, and implement process enhancements in a fast-paced environment.
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Preferred Qualifications:
- Experience with product lifecycle management (PLM) systems.
- Familiarity with design control processes and usability engineering.
- Certified Quality Auditor (CQA) or Six Sigma certification is a plus.
Details
The role is a remote position, with a 40-hour workweek, flexible working hours, and occasional overlap with the US team.
Responsibilities
QMS Maintenance:
- Oversee the ongoing maintenance and improvement of the QMS in compliance with ISO 13485, FDA 21 CFR Part 820, Health Canada, TGA, and MDSAP requirements.
- Manage document control, internal audits, CAPA processes, and management review activities.
- Ensure timely updates to quality policies, procedures, and work instructions.
Product Compliance Reviews:
- Conduct product compliance assessments to ensure adherence to regulatory, customer, and company requirements.
- Review and approve product documentation, including design history files (DHF) and risk management files.
- Support post-market surveillance activities, including complaint handling and adverse event reporting.
SOP Training & Implementation:
- Develop and conduct training sessions on QMS requirements, SOPs, and regulatory updates.
- Maintain training records and ensure personnel competency in quality system processes.
- Act as a point of contact for employees seeking guidance on quality procedures.
Daily Quality Adherence:
- Monitor daily operations to ensure compliance with established quality policies and procedures.
- Work closely with manufacturing, R&D, and regulatory teams to address quality-related issues proactively.
- Support nonconformance investigations and root cause analysis efforts.
- Ensure QTI has completed the final acceptance of products from the contract manufacturer to meet process validation compliance.
- Ensure complaints are properly communicated to contract manufacturers.
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Design Review Facilitation:
- Collaborate with the R&D team to implement and maintain design review checklists.
- Ensure design control requirements are met throughout the product development lifecycle.
- Assist in risk assessments, verification, and validation activities.
- Lead efforts for adherence to Risk Management and Post-Market Surveillance for FDA, TGA, and Health Canada.
Audit & Regulatory Compliance Support:
- Prepare and support external audits, including MDSAP, Health Canada, FDA, TGA, and notified body inspections.
- Lead internal audits to assess compliance with QMS requirements and identify areas for improvement.
- Work with cross-functional teams to ensure audit findings are addressed and corrective actions are implemented.
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
Recruiting process
- Step 1 ‘Screening call with HR’
- Step 2 ‘Assessment task’
- Step 3 ‘Interview with department lead’
- Step 4 - ‘Cognitive Assessment’
- Step 5 - ‘Final interview’
- Step 6 - ‘Reference Check’
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