QA Specialist

Mpya Sci & Tech AB / Organisationsutvecklarjobb / Stockholm
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Are you an experienced and result-oriented QA? Do you have experience from Med Tech industry and enjoy working broadly with quality issues? Then this role as a QA Specialist 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 QA Specialist to join the team.

The role

As a QA Specialist, you will be part of an impactful quality team. You will be responsible for maintaining high standards for quality of processes and products at CareDx. In this role, you will work with general quality issues mostly regarding the Stockholm site. The quality task is related to both development, manufacturing and also testing services. In your role you will have frequent communication and close collaboration cross functionally throughout the company.

Responsibilities

• Handling Batch Releases, Document control, NCR/CAPA, change control, Validations and Supplier Management.
• Be the QA representative in projects to ensure efficient implementation of applicable quality requirements throughout development and maintenance of CareDx's products.
• Support internal and external audits.
• Work with continuous improvement initiatives.

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.
• Minimum 2 years' experience from Quality Assurance.
• Fluent English, verbally and in written, Swedish is meritorious.
• Previous experience from working within Medical Device and familiarity with regulations such as ISO 13485, GMP, MDSAP and IVDD/IVDR is meritorious.
• Meritorious with experience within supplier management.

Interested?

In this recruitment, CareDx is collaborating with Mpya Sci & Tech. Please submit your application at www.mpyascitech.com no later than the 27th of August. Interviews will be scheduled continuously. Contact Talent Advisor Ellinor Crafoord at ellinor.crafoord@mpyascitech.com , 072-176 51 67 or 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

Ersättning
Enligt överenskommelse

Så ansöker du
Sista dag att ansöka är 2023-08-27
Klicka på denna länk för att göra din ansökan

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Mpya Sci & Tech AB (org.nr 559210-7204)

Arbetsplats
Mpya Sci & Tech

Jobbnummer
7996635

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