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
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
Completed technical or scientific training at HF, technical college or university
Three or more years of professional experience in Quality Management (ISO, 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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