Senior QA Specialist, CareDx
Mpya Sci & Tech AB / Elektronikjobb / Stockholm
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hela Sverige Are you an experienced QA looking for the next step in your career? Do you have experience working within the Life Science industry and want to work in a familiar team with life-saving products? Then this role as a Senior 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. This position is located at the CareDx site in Stockholm where they develop and manufactures HLA-typing products. The products (assays and software) 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 is now looking for their next QA Specialist to join the team.
About the role
As a Senior QA Specialist, you will assist in developing, implementing and maintaining the company's Quality Management System (QMS) with a drive and passion for continuous improvements.
The role includes, but is not restricted to:
• Review laboratory and equipment records, QC testing data and software development testing.
• Conduct Product lot release.
• Issue, review and approve quality documents.
• Participate in internal and external audits.
• Handle non-conformances, corrective and preventive actions.
• Handle change control requests.
• Support Supplier Management.
• Be the Trainer to company personnel when required. Advise company personnel on all matters pertaining to the quality of company operations in compliance with quality requirements. This includes guidance in product design and development, risk assessment and production.
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.
Your profile
• Bachelor level (or higher) in a degree in Medical Science or equivalent.
• Experience of working in a regulated medical device (or equivalent) environment (minimum 5 years) with at least 2 years in a QA role.
• Relevant experience from laboratory medical testing, research and development or medical device (or equivalent experience).
• Experience quality system according to ISO 13485.
• Relevant experience from GMP, MDSAP, IVDD/IVDR, IEC 62304 and ISO 14971 is meritorious.
• Fluent in English and Swedish, both spoken and written.
How to apply
In this recruitment process, CareDx is collaborating with Mpya Sci & Tech. For questions about the position, please feel free to contact Talent Advisor Jasmin Khatibi,
jasmin.khatibi@mpyascitech.com, phone 076-163 63 00. We conduct ongoing selection, so do not delay your application as the position might be filled before the final application deadline. Please apply for the position via mpyascitech.com, no later than 28th of January.
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 2024-01-28
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 8336601
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