CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. The QA team in Stockholm is currently looking for a dedicated Senior QA Specialist to support their mission build a robust quality culture and ensuring product compliance.

The position:
As Sr QA Specialist, you will also be deputy QA Manager in the group. You will have a senior position including great responsibility in decisions and critical QA tasks.  You will take on a diverse QA role, including a wide range of quality assurance activities and collaboration with several functions and Quality stakeholders in the company. This position has focus on maintaining and enhancing the Quality Management System (QMS) to ensure ongoing excellence as well as document control. The role combines both strategic and hands-on responsibilities throughout all stages of the product lifecycle.

Key Responsibilities include but not limited to:

• Work with the implementation, oversight, and continuous improvement of quality management system (QMS).
• Create and update QMS documentation in accordance with CareDx procedures and applicable regulations, ISO/IEC standards and MDSAP guidelines.
• Manage non-conformances, corrective and preventive actions.
• Review and approve technical documents.
• Responsible for overall training in quality standards.
• Perform evaluation and audit of distributors and suppliers.
• Participate, as Quality representative, in products development projects.
• Support daily QA activities (e.g., product release, review change control requests).

Qualifications:

• M.Sc. in Life Sciences, biomedical engineering, or related field.
• 5+ years of experience in RA/QA role within medical device.
• Extensive understanding in Quality Management for medical device.
• Extensive knowledge in ISO 13485.
• Strong collaboration- and organizational skills.
• Excellent communication skills in English, both spoken and written.
• Good skills in Swedish, both spoken and written.

Why Join Us:

CareDx offers a senior role where you will work with both tactical and operational responsibilities. You will join a dynamic team and work with frontline diagnostic products.

Application:

In this recruitment CareDx is collaborating with SallyQ. If you are interested in the position and want further information, contact Senior Recruitment Consultant Ellinor Crafoord 079-3554257 or ellinor.crafoord@sallyq.se

Application deadline is 20th of March 2025.

About CareDx

CareDx is a global medical technology company specializing in diagnostic solutions and services for transplant care. The company focuses on improving outcomes for organ transplant patients by offering innovative products that help doctors monitor transplant health and detect early signs of organ rejection. At the Stockholm site they develop and produce pre-transplant diagnostic kits for a global market.