Head of Quality Management (SaMD, 80%/100%)

Our established international team of software engineers and data scientists is seeking new colleagues to help building the world's leading AI-based solution (software as a medical device - SaMD) that interprets MRI (magnetic resonance imaging) of all body regions for orthopedic and other clinical conditions. Check out one of our papers validating one of our lumbar spine features here.

For our medical device AI software, we are looking for an experienced person who will continue and lead our quality management and maintain our regulatory affairs. 

Your role

• Responsibility for the company's quality management
• Responsibility for extending, maintaining, and certifying our eQMS according to ISO 13485
• Facilitating internal audits and inspections by notified bodies, authorities, and customers
• Planning and controlling onboarding of new employees
• Conducting regular training on quality management with employees
• Adapting our QM system to new markets and requirements
• Responsibility for our organization and products to meet legal requirements, regulations and standards

Your qualifications

• Completed technical or scientific training at HF, technical college or university
• Three or more years of professional experience in Quality Management (ISO 13485, MDR, CFR 21 Part 820, MDSAP), relating to medical devices of class II or higher
• Appropriate regulatory management experience (510(k), de novo, CE Mark) in an area with a lot of regulatory uncertainties (cloud, artificial intelligence, machine learning) is a strong plus
• Experience with software development and the testing of software is a plus
• Appropriate management experience (preferably as an auditor or QM officer)
• Ability to work independently in a fast-paced environment, managing multiple, competing priorities
• Ability to quickly get into and learn the necessary skills for new tasks/challenges
• Strong communication and organizational personality with leadership and teamwork skills
• Business fluency in English (spoken and written). German is a plus.
• Swiss or EU/EFTA work permit

What we offer

• Collaborative modern workspace environment with abundant medical data to be explored and turned into value for healthcare providers
• Contribute to a highly innovative medical AI software device
• High impact on the company's achievements in direct collaboration with the leadership team
• Flexible work times and hybrid work scenarios