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FDA Quality Assurance Manager - Full Time - Remote

April 27, 2026

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.<div>Experity offers the following:<ul><li>Benefits – Comprehensive coverage starts first day of employment and includes Medical, Dental/Orthodontia, and Vision.</li><li>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!</li><li>Employee Assistance Program - This robust program includes counseling, legal resolution, financial education, pet adoption assistance, identity theft and fraud resolution, and so much more.</li><li>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.</li><li>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.</li><li>Career Development – Experity maintains a learning program foundation for the company that allows Team Members to explore their potential and achieve their career goals.</li><li>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.</li><li>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.</li></ul>Compensation: Budgeted between $103,000 and $132,000 dependent upon years of applicable experience.Responsibilities:<ul><li>Develop, implement, and maintain the Quality Management System (QMS), including SOPs and document control.</li><li>Ensure compliance with 21 CFR Part 820 and applicable standards (e.g., ISO 13485, ISO 14971).</li><li>Establish and manage CAPA (Corrective and Preventive Action) processes.</li><li>Oversee complaint handling and evaluate reportability requirements.</li><li>Ensure design controls and software validation processes are in place and followed.</li><li>Conduct internal audits and prepare for FDA inspections.</li><li>Support risk management activities across the product lifecycle.</li><li>Train cross-functional teams on quality and compliance requirements.</li><li>Other duties as assigned.</li></ul>Business Impact:<ul><li>Ensures regulatory compliance (FDA, ISO) to enable uninterrupted product availability and market access.</li><li>Reduces organizational risk through strong CAPA processes, audit readiness, and complaint handling.</li></ul>Travel: <ul><li>Ability to travel as needed.</li></ul>Education and Experience: <ul><li>Bachelor's degree in Computer Science, Life Science, or Quality/Regulatory or equivalent combination of education and experience.</li><li>3–7 years of experience in medical device quality or a regulated industry.</li><li>Working knowledge of FDA Quality System Regulation (21 CFR Part 820).</li><li>Experience with QMS implementation, CAPA systems, and internal audits.</li><li>Familiarity with software development lifecycle (SDLC) and validation principles.</li></ul>Preferred:<ul><li>Experience supporting FDA inspection or ISO audits.</li></ul> Every team member exhibits our core values:<ul><li>Team First</li><li>Lift Others Up</li><li>Share Openly</li><li>Set and Crush Goals</li><li>Delight the Client</li></ul></div>Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the <a href="https://www.eeoc.gov/poster" target="_blank" rel="noopener noreferrer">Know Your Rights</a> notice from the Department of Labor.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...