Quality Assurance Expert for Medical Devices

4 days ago


Stockholm, Stockholm, Sweden SallyQ AB Full time

Job Overview:

CareDx is a global medical technology company specializing in diagnostic solutions and services for transplant care. We are committed to improving outcomes for organ transplant patients by offering innovative products that help doctors monitor transplant health and detect early signs of organ rejection. As a key member of our team, you will have the opportunity to work on cutting-edge technologies and contribute to the development of life-saving products.

Key Qualifications:

Master's degree in Life Sciences, biomedical engineering, or a related field.At least 5 years of experience in a RA/QA role within medical devices.Extensive understanding of Quality Management for medical devices and relevant regulatory frameworks.Strong knowledge of ISO 13485, IVDD/IVDR, and MDSAP.Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.Fluency in English, both spoken and written, and good proficiency in Swedish.

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