FDA Quality Assurance Manager - Remote

Overview

Experity is a mission-driven team transforming on-demand healthcare across the U.S., empowering urgent care clinics with industry-leading software that makes care faster, easier, and more patient-focused. Joining us means doing meaningful work that directly improves the healthcare experience for millions—from helping families access care quickly to ensuring clinics run smoothly behind the scenes.

In Short

• Develop, implement, and maintain the Quality Management System (QMS).
• Ensure compliance with 21 CFR Part 820 and applicable standards.
• Establish and manage CAPA processes.
• Oversee complaint handling and evaluate reportability requirements.
• Conduct internal audits and prepare for FDA inspections.
• Support risk management activities across the product lifecycle.
• Train cross-functional teams on quality and compliance requirements.
• Work in a mission-driven environment focused on healthcare improvement.
• Participate in team-building activities and company events.
• Enjoy flexible work scheduling and comprehensive benefits.

Requirements

• Bachelor's degree in Computer Science, Life Science, or Quality/Regulatory.
• 3–7 years of experience in medical device quality or a regulated industry.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820).
• Experience with QMS implementation and CAPA systems.
• Familiarity with software development lifecycle (SDLC) and validation principles.
• Preferred: Experience supporting FDA inspection or ISO audits.

Benefits

• Comprehensive medical, dental, and vision coverage starting on the first day.
• Eligibility for synthetic ownership after one year of employment.
• Employee Assistance Program offering various support services.
• Generous Paid Time Off (PTO) plan.
• Career development programs to explore potential and achieve goals.
• Competitive pay with quarterly bonuses and a 401(k) match.