Senior Manager QA

CareDx is a leading company in transplant medicine. It is a global company with Head Quarters in California, and offices in both Europe and South Pacific. The CareDx Stockholm site, with office at Kungsholmen, develops and manufactures HLA-typing products. The products are developed under Design Control and EN ISO 13485:2016 and are globally used as an aid in transplantation matching process between recipient and donor.

The Stockholm site employs 55 colleagues within R&D, Manufacturing, Supply, Quality Assurance, Regulatory Affairs, Commercial and Finance. We have two QA positions in Sweden currently and for one of these we are looking for a Senior QA Manager who can be the QA lead for the site, work operationally as well as support in strategic issues.

As a Senior QA Manager your main responsibility is to ensure that the Stockholm product development and manufacturing processes are compliant with CareDx's Quality Management System (QMS), that the QMS is efficiently managed and that it is continuously improved. You will be responsible for the QA team and you will be part of the site management team. The role collaborates with all functions at the site, as well as with several functions within the global organization. The plan for this role is that you will report to the US and there will be a great extent of collaboration with the Australian CareDx site.

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

• Lead and support the colleagues in the QA team
• 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 with the goal 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 organization. Integrity, accountability, and result-orientation are important values for us. We are looking for a candidate that can contribute to this approach and core values.

Qualifications:

• University degree Life Science or Technology or equivalent
• Minimum 7 years of experience from Quality Assurance

• Minimum 3 years of experience with Medical Device and EN ISO 13485
• Fluent English, verbally and in written, Swedish is meritorious

CareDx Stockholm offers a Senior QA Manager role where you get to work in a growing organization with best in-class products.

Interested?

Please submit your application no later than 15th January. 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