About Mira
Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 200,000 customers. In 2023, they were recognized by Inc. 5000 as America's fastest-growing femtech company. We started our company to help women and individuals reach their parenthood dreams and make their fertility journey smoother.
Mira’s most important breakthrough was inventing the market's only FDA-compliant at-home
fertility monitor with
quantitative technology. Since the beginning, they have been on a mission to develop data-driven hormonal health solutions to help women make confident health decisions during every stage of their lives—from the menstrual stage to menopause. Mira offers solutions to test, boost, and navigate fertility—starting from comprehensive hormone testing and supplements to fertility coaching and online courses.
We are committed to helping our customers achieve the highest possible success rates and outcomes; that is why our focus is on personalized care, the use of the most cutting-edge technology, and science-backed data.
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 want to challenge yourself at a high-growth startup and make a difference for women's health please join us!
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
- 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 Risk Management and Post-Market Surveillance efforts 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.
Requirements
Qualifications:
- 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.
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.
What We Offer
- You will work with a dedicated, highly-engaged, international team of professionals who are passionate about helping couples and individuals start their families
- We have a fast paced and collaborative work environment where we encourage open communication, ownership and independence
- In addition to competitive salary we offer performance-based bonus system based on OKR
- We provide professional development opportunities - training courses, workshops and seminars
Recruiting process
Step 1 ‘Screening call with HR’ -
Step 2 ‘Assessment task’ -
Step 3 ‘Interview with department lead’ -
Step 4 ‘Final interview with Director of Quality and Regulatory'
