Quality Systems Specialist

About Mira

Mira, headquartered in San Francisco, specializes in hormonal health by offering integrative care and hormonal testing to over 300,000 customers. Recognized in 2023 as America’s fastest-growing femtech company, Mira innovated by creating the only FDA-compliant at-home hormone monitor with quantitative testing technology. The company's mission is to empower women to understand their bodies and make informed health decisions related to hormone health at all life stages.

Position Overview

The Quality Systems Specialist is entrusted with managing the Quality Management System (QMS), executing product compliance evaluations, training staff on Standard Operating Procedures (SOPs), and ensuring consistent adherence to quality requirements. This role enables collaboration with R&D to facilitate design review checklists supporting product development and regulatory compliance. Additionally, support for audits and ensuring compliance with FDA, Health Canada, Therapeutic Goods Administration (TGA), and Medical Device Single Audit Program (MDSAP) is vital.

Key Responsibilities

• Maintain and enhance the QMS to comply with ISO 13485, FDA 21 CFR Part 820, Health Canada, TGA, and MDSAP standards.
• Manage document control, conduct internal audits, oversee CAPA processes, and coordinate management reviews.
• Perform product compliance evaluations, review design history files and risk management documentation.
• Support post-market surveillance including complaint management and adverse event reporting.
• Develop and deliver training sessions on QMS, SOPs, and regulatory changes, maintaining training documentation and ensuring team competency.
• Monitor daily operations for adherence to quality policies, cooperate with manufacturing, R&D, and regulatory teams to proactively solve quality issues.
• Lead efforts to validate processes and ensure contract manufacturers meet quality criteria, including complaint communication.
• Collaborate with R&D on design review checklists, assist with risk assessments, verification, and validation activities.
• Lead internal and support external audits and inspections, ensuring corrective actions are implemented effectively.

Candidate Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related discipline.
• Minimum 3 years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance within IVD or Medical Device sectors.
• Comprehensive knowledge of ISO 13485, FDA QSR 21 CFR Part 820, Health Canada Medical Device Regulations, TGA, and MDSAP.
• Proficient in QMS software, document control, audit management, CAPA handling, and supplier quality oversight.
• Experience conducting audits, managing supplier compliance—including international contract manufacturers.
• Capability to manage multiple quality projects, perform data-driven continuous improvement, and implement process optimizations in a dynamic environment.
• Preferred: familiarity with product lifecycle management systems, design control, usability engineering, and certifications like CQA or Six Sigma.

Benefits and Work Conditions

• Join a pioneering femtech company committed to advancing women’s health globally.
• Work with a highly motivated international team making a significant societal impact.
• Engage in a fast-paced startup atmosphere with meaningful contributions to company growth and strategic decisions.
• Opportunities for professional growth including building and leading teams.
• Flexible, fully remote work setting promoting autonomy and independence.
• Receive a competitive salary with performance-based bonuses aligned to company objectives.

Additional Information

• This is a full-time remote role requiring a 40-hour workweek with flexible hours and occasional coordination with US teams.
• The recruitment process comprises multiple stages: HR screening, assessment task, department lead interview, cognitive assessment, final interview, and reference check.