Job Quality Manager @ XVisionAI

Quality Manager - QMS for Medical Device Software

Responsibilities:

• Ensure the medical device quality management systems are compliant to ISO 13485, MDR, and other device-specific requirements
• Implement and report on the effectiveness of the Medical Device QMS to the management across the business
• Perform and coordinate internal and external audits of the Quality Management System
• Ensure the Quality Management System is updated and maintained to ensure it is compliant with industry and country regulations
• Provide input to the Post Market Regulatory process for Medical Devices

Requirements:

• Proven track record at managing and developing Medical Device QMS to ISO 13485 and other standards/directives
• A diploma, certificate or other evidence of formal qualification or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Must have a good knowledge of the new MDR and how that impacts requirements for the Medical Device QMS
• Will be comfortable presenting to the core team as well as conducting training sessions to the team
• Will be a strong leader with excellent communication skills

The ideal candidate:

• Strong analytical and technical skills.
• Self-motivated with the ability to prioritize, schedule and meet deadlines;
• Good organizational, writing and verbal communication skill
• Experience working in a regulated industry (Medical Device, Medical Software)
• Minimum of two years’ experience in Quality Engineering

Why join us?

• Experience a young & dynamic learning environment where you can grow
• Work with a small, agile team with a focus on modern & efficient software development
• Work directly with the founders & make meaningful contributions to the company’s activities
• Work in a fast-growing start-up
• Manage your own time via flexible working hours

Company description

XVision is a company that was founded in 2017 by a team of four software developers with knowledge in artificial intelligence, deep learning and the will to optimize processes in the world of healthcare in order to save human lives.

The company deeply believes that radiology can only benefit from having doctors and artificial intelligence work together in the difficult process of diagnostics. This belief gave birth to the company's main product: an application that uses a suite of machine learning algorithms to analyze digital x-rays, in order to assist doctors in interpreting them.

Today XVision is a well-known tool in the Romanian radiology community, with multiple public hospitals testing and using the system.

💌 Do you wanna work together?

P. S Don`t forget to attach your CV/ Linkedin Profile