Senior Quality System Specialist в Remedy Logic

Contact:

@vectorvp

Imagine a world where healthcare is more effective and accurate, where diagnoses are made with unprecedented precision. At Remedy Logic, we're turning this vision into a reality. With our cutting-edge AI technology, we're transforming the way healthcare is delivered. 

Already, we've partnered with over 70 MRI facilities, making the lives of hundreds of radiologists easier and more efficient. Our groundbreaking product identifies 15+ lumbar spine abnormalities, pushing the boundaries of medical knowledge.

We are looking for passionate individuals to join our team and help us shape the future of medicine. Together, we will redefine what's possible, push the boundaries of innovation, and make a lasting impact on the world of healthcare. Your expertise and dedication are the missing piece of the puzzle.

In this exciting role as a Senior Quality System Specialist, you will have responsibility of working with team members to ensure proper implementation of procedures into the Quality Management System (QMS) and operations.

Responsibilities:

• Prepare documentation which complies with the U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements.
• Troubleshoots existing processes and technologies. Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
• Conduct thorough reviews and edits of documents to maintain consistency, clarity, and adherence to company standards and industry best practices.
• Manage document version control and maintain an organized document repository to ensure accessibility and traceability.
• Identify opportunities for process improvements and contribute to the development and maintenance of documentation best practices.

Requirements:

• Bachelor’s degree or equivalent experience in Computer Science, Information Technology, Engineering or related discipline;
• 4+ years of experience in Quality and/or regulated industry OR Advanced degree with 2+ years of experience in Quality and/or regulated industry.
• Strong technical writing and documentation review skills.
• Exceptional analytical skills, keen attention to detail, and the capability to distill complex information into clear and concise documents.
• Ability to work on assignments requiring independent action and a high degree of initiative to resolve issues.

Exceptional skills:

• Experience with FDA QSR and other medical device regulations, MDSAP, ISO13485 and EU MDR. 
• Experience with FDA 510(k), de novo submission, establishment registration and product listing.

We offer:

• Fully remote work: Enjoy the flexibility of working from anywhere in the world.
• Competitive salary: We believe in fair compensation and recognize the value of your skills and contributions. You'll receive a salary that reflects your expertise and experience.
• Stock options: As a valued team member, you'll have the opportunity to own a part of our success story through stock options. Get ready to share in our growth and achievements.
• Amazing team culture: Join a close-knit, friendly team that values collaboration, respect, and a positive work environment. We believe in supporting one another and fostering a sense of camaraderie.
• Your voice matters: We value your unique perspective and encourage you to share your ideas. Be part of the decision-making process and have a real impact on our product's development.
• Pioneering in medicine/radiology: Experience the thrill of being at the forefront of medical and radiology breakthroughs. Work on cutting-edge technology that is shaping the future of healthcare.

So, are you ready to join Remedy Logic's revolution? Together, let's create a future where healthcare is smarter, more precise, and accessible to all.