Senior QA Specialist

CareDx is a leading player in transplant medicine. It is a global company with a mission to improve transplant patient outcomes through innovative, noninvasive testing solutions throughout the entire patient journey. At the Stockholm site CareDx develops and manufactures HLA-typing products. The products are developed for the global market and are used in transplantation as part of the matching between recipient and donor.

The department for Quality & Regulatory Affairs consists of 6 people globally and the Stockholm team consists of a regulatory manager and a QA Specialist and team is now looking for a Senior QA position. The team reports to the Global Senior QA/RA Manager, who sits in Australia.

As a Senior Specialist within the quality management team, you are responsible for ensuring that the products and manufacturing processes at the Stockholm site is compliant with CareDx's quality systems.

The role collaborates a lot with R&D and manufacturing on site, as well as with several functions within Global CareDx.

Your duties include:

• Development and maintenance of the QMS in terms of compliance with national and international regulatory standards and guidelines for the development and production of IVD medical devices.
• You will review manufacturing documentation and test results for quality control and batch release.
• Prepare for and lead the site in external audit execution and be responsible for internal audits.
• Be the Quality Management Representative for the site.
• Drive continuous improvement initiatives.
• Ensure compliance with the quality system for the site including audit readiness.

At CareDx, we have a solution-oriented approach to our processes where we “lean in” for the team, and to improve patient outcomes. We have a strong collaborative environment and encourage dynamic approaches to problem solving making use of the extensive expertise available throughout the CareDx organisation. We are looking for a candidate that can contribute to this approach and core values.

Qualifications:

• University degree Life Science or Technology or equivalent
• Experience with ISO13485 and other quality system ISO standards are extremely advantageous.
• Approximately 5 years of experience from Quality Assurance
• Experience working with Medical Device
• Fluent Swedish and English, verbally and in written

CareDx Stockholm offers a senior Quality Assurance role where you get to work in a growing organization with best in-class products.

Interested?

Please submit your application no later than 30th September. Contact Talent Advisor Ellinor Crafoord at +46721765167 or ellinor.crafoord@mpyascitech.com for further questions.

About CareDx:

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.

Read more on: www.caredx.com