CK QLS are working exclusively with an exciting, innovative start up company who are utilizing AI along with a medical device. Our client’s software provides AI for the diagnosis of MRI, providing healthcare professionals with results via text and images. Our client, hopes to be moving to commercialization in early 2023. The role is a hybrid role, with 2 days per week at the site, based in Zurich.
The role is a Quality Manager, who would be responsible for maintaining the eQMS; putting in place procedures and processes the enhance the performance and then rolling out training and ensuring compliance throughout the business. The QMS would be in line with ISO13485 and the candidate would have strong knowledge of the regulations as well as MDR, MDSAP, CFR 21 Part 820, IEC 62304.
The ideal candidate would have experience and knowledge of SaMD; be experienced with risk management and would be knowledgeable with release management. They would be an approachable individual who is open to discussion amount the team and has the mindset of working within a start up organization.
Please reach out to Jocelyn Blackham at email@example.com if this role could interest you.