Medical Device Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team. As a key member of our Clinical and Regulatory department, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.
Your primary focus will be on defining and delivering our strategy to maintain superior product quality and placing our products on new markets. You will be the expert in all corners of our Quality Management System, engaged in all stages of product development, and responsible for the structure of technical documentation and internal quality processes.
The ideal candidate will have at least 1 year of experience in quality assurance and/or regulatory affairs, with a strong understanding of quality management systems and regulatory requirements within MDR and ISO 13485. You will also have excellent communication skills in English and experience working within or leading cross-functional projects.
Main Responsibilities- Co-drive product release projects in collaboration with the project manager from the development team
- Support other departments in design control
- Take lead on the risk analysis for new products, with support from our clinical and development team
- Review and revise QMS procedures to ensure they are efficient and effective
- Assist management in prioritizing regulatory approval activities based on strategy and market potentials
- Create and coordinate product submissions for the devices we develop (possibly supported by consultants)
- Train the company in QMS procedures
- Participate in audits, both internal and external
At Radiobotics, we believe in transparency, integrity, and a culture of continuous learning. We strive to solve the global need for radiologists while ensuring every patient receives expert-level care. Our vision is to augment routine X-rays of the musculoskeletal system and enable non-specialists to report them with the assistance of our products.
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