FDA Quality Assurance Manager - Full Time - Remote

Experity • Machesney Park, IL

5d • $103,000 - $132,000 • Remote

About The Position

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. If you want to make a real impact alongside innovative, dedicated teammates while contributing to a trusted platform that’s becoming the operating system for on-demand care, Experity is the place to grow your career. Experity offers the following: Benefits – Comprehensive coverage starts first day of employment and includes Medical, Dental/Orthodontia, and Vision. Ownership - All Team Members are eligible for synthetic ownership in Experity upon one year of employment with real financial rewards when the company is successful! Employee Assistance Program - This robust program includes counseling, legal resolution, financial education, pet adoption assistance, identity theft and fraud resolution, and so much more. Flexibility – Experity is committed to helping team members face the demands of juggling work, family and life-related issues by offering flexible work scheduling to manage your work-life balance. Paid Time Off (PTO) - Experity offers a generous PTO plan and increases with milestones to ensure our Team Members have time to recharge, relax, and spend time with loved ones. Career Development – Experity maintains a learning program foundation for the company that allows Team Members to explore their potential and achieve their career goals. Team Building – We bring our Team Members together when we can to strengthen the team, build relationships, and have fun! We even have a family company picnic and a holiday party. Total Compensation - Competitive pay, quarterly bonuses and a 401(k) retirement plan with an employer match to help you save for your future and ensure that you can retire with financial security. Compensation: Budgeted between $103,000 and $132,000 dependent upon years of applicable experience.

Requirements

• Bachelor's degree in Computer Science, Life Science, or Quality/Regulatory or equivalent combination of education and experience.
• 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, CAPA systems, and internal audits.
• Familiarity with software development lifecycle (SDLC) and validation principles.

Nice To Haves

• Experience supporting FDA inspection or ISO audits.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS), including SOPs and document control.
• Ensure compliance with 21 CFR Part 820 and applicable standards (e.g., ISO 13485, ISO 14971).
• Establish and manage CAPA (Corrective and Preventive Action) processes.
• Oversee complaint handling and evaluate reportability requirements.
• Ensure design controls and software validation processes are in place and followed.
• 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.
• Other duties as assigned.

Benefits

• Benefits – Comprehensive coverage starts first day of employment and includes Medical, Dental/Orthodontia, and Vision.
• Ownership - All Team Members are eligible for synthetic ownership in Experity upon one year of employment with real financial rewards when the company is successful!
• Employee Assistance Program - This robust program includes counseling, legal resolution, financial education, pet adoption assistance, identity theft and fraud resolution, and so much more.
• Flexibility – Experity is committed to helping team members face the demands of juggling work, family and life-related issues by offering flexible work scheduling to manage your work-life balance.
• Paid Time Off (PTO) - Experity offers a generous PTO plan and increases with milestones to ensure our Team Members have time to recharge, relax, and spend time with loved ones.
• Career Development – Experity maintains a learning program foundation for the company that allows Team Members to explore their potential and achieve their career goals.
• Team Building – We bring our Team Members together when we can to strengthen the team, build relationships, and have fun! We even have a family company picnic and a holiday party.
• Total Compensation - Competitive pay, quarterly bonuses and a 401(k) retirement plan with an employer match to help you save for your future and ensure that you can retire with financial security.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1-10 employees