RadNet is a public company operating 350+ medical imaging centers across the US. Its AI division – comprising subsidiaries Aidence, DeepHealth, and Quantib – develops and markets AI-based software products for the early detection of breast, lung, and prostate cancers with the purpose of bringing the world’s best doctor to every patient.
In the AI division, we are dedicated to addressing the most complex challenges faced by radiologists and enhancing their ability to focus on valuable tasks. Medical images hold the secrets to diseases that both physicians and we aim to unveil. Our mission is to empower radiologists with fast and accurate artificial intelligence software, enabling them to detect even the subtlest changes within the human body. If you’re passionate about advancing healthcare through artificial intelligence, we invite you to join our team.
We are not just a workplace; it’s a collaborative environment where teamwork is paramount. We’re a close-knit, growing team, embracing an agile approach that allows us to swiftly adapt to challenges and opportunities alike.
Role Summary
The Quality Assurance Specialist is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Quality Assurance Engineer will be responsible for collaborating cross-functionally to support and guide product development. The Quality Assurance Engineer will take ownership of applicable processes within the Quality Management System, such as QMS training, complaint and CAPA management.
Essential Duties and Responsibilities
As the Quality Assurance Specialist, this position will:
- Work cross-functionally with the Engineering, Clinical and Marketing teams to develop new products and implement design changes to existing DeepHealth products.
- Take ownership of applicable Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency.
- Work cross-functionally to integrate products as a result of corporate and/or product acquisitions
- Work as a team member with the Quality Assurance team to ensure compliance with US and OUS standards and regulations.
PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.
Requirements
Minimum Qualifications, Education and Experience
- Bachelor’s degree in a relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience).
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred.
- Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required.
- 2 – 4 years working in a regulated industry (FDA and Software as a Medical Device preferred).
- Participation in regulatory audits is a plus.
- Excellent written and oral communication skills.
What We Offer
- Join a dynamic team with expertise in various fields.
- Collaborative and agile work environment.
- Continuous learning opportunities to enhance your professional skills.
- Fully remote working environment with flexibility in work hours.
- A salary in line with job level and experience.
* At this time, the company can only support visa sponsorship between European countries. We can not support visa sponsorship internationally between the US and Europe.
