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

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

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