Senior QA Specialist, CareDx

Are you an experienced QA looking for the next step in your career? Do you have experience working with Medical Device? Do you want to work in a familiar team with life-saving products? Then this role as Senior QA Specialist SW at CareDx is for you!

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 Quality department in Stockholm team consists of four QA Specialists and is now looking for a Senior QA Specialist to join the team.

The role

As a Senior QA Specialist SW, your responsibility is to ensure compliance with the standards and regulations for the design, development, more specifically software as a medical device.

In this role, you will be involved in cross-functional collaborations with both external and internal parties, it is therefore important that you have an adaptability to work with diverse teams with varying opinions and perspectives.

Responsibilities

• Creating and improving QMS and product documentation for software as medical device.
• Ensuring compliance with software development lifecycle requirements, policies and procedures (IEC 62304).
• Performing design control and risk management activities IEC 62304 and ISO 14971.
• Giving support in the creation of regulatory submission documentation.
• Assist in internal and external audits.
• Handling of software related nonconformities.
• Handling of software related Change Controls.
• Handling of software releases.
• Handling of software validations.

At CareDx we have a solution-oriented approach to our processes and our engaged in bringing world class molecular diagnostic tools to transplant medicine. We have a strong collaborative environment and encourage dynamic approaches to problem solving making use of the extensive expertise available throughout the CareDx organization. We are looking for a candidate that can contribute to this approach and core values.

Qualifications

• University degree in Life Science or Technology or equivalent.
• 5+ years's experience from Quality Assurance, preferably within ISO 13485 or equivalent.
• Experience of working with ISO/IEC 62304, ISO 14971 and IEC 62366.
• Experience of working with ISO13485, MDSAP, IVDD/IVDR is meritorious.
• Fluent English, verbally and in written, Swedish is meritorious.

Interested?

In this recruitment, CareDx is collaborating with Mpya Sci & Tech. Please submit your application at www.mpyascitech.com no later than the 22th of October. Interviews will be scheduled continuously. Contact Talent Advisor Jasmin Khatibi at jasmin.khatibi@mpyascitech.com , 076- 163 63 00 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