QA Associate Molecular Biology Tools
Takara Bio Europe AB / Organisationsutvecklarjobb / Göteborg
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Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of products since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vitro diagnostic) kits using PCR technology to its portfolio.
To strengthen our ability to support our customer needs Europe, TBESF will expand its operations into molecular biology tools and we are now looking for a QA associate to join our team. You will work closely together with our project manager to prepare our facility and management system for the implementation of molecular biology tools assembly at the site. The long-term goal is an 13485-certified manufacturing site with QC capabilities to support our European customers. In the near future we will contribute with ISO 9001 products assembled according to customer needs.
We are looking for a person with high quality focus experienced in the MDR and/or IVDR area. Preferably you have been working with both implementation projects for manufacturing as well as quality assurance in general within medtech. You feel confident in your quality role and understand the importance of being pragmatic but within the boundaries. You will be part of the quality team and report to the Associate Director Quality.
Work description
Project phase:
Drive the quality agenda during the implementation phase
Transfer of quality information from affiliate sites
Update our current QMS to support our molecular diagnostics business (initially ISO9001, long term ISO13485)
Operation phase:
Management of quality related issues
Manage change controls and deviations and other processes supporting the production
Review of documentation
Manage, evaluate and qualify suppliers
QMS administration
Support customer requests
Host and/or support audits
Matching candidate
Master's Degree in relevant area
Work experience within quality for medical device and/or IVD (ISO13485/MDR/IVDR)
Participated in QMS implementation and/or update and/or administration
Experience of supplier management
Strong quality agenda
Auditor and experience of hosting audits
You will be an important part of the sites new offer within molecular biology. There will be a variety of tasks and the ability to work independently is required. We can offer you a familiar environment where each person is doing a difference.
Welcome with your application no later than April 23, 2023 by email to
anna_gunnerling@takarabio.com, subject QA Mol Biol.
We will start the evaluation of candidates as they arrive, and the position can be filled before due date.
For more information please contact
anna_gunnerling@takarabio.com, phone +46 765 25 09 61
Så ansöker du Sista dag att ansöka är 2023-04-23
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "QA Molecular Biology Tools".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Takara Bio Europe AB (org.nr 556613-7971)
Arvid Wallgrens Backe 20 (
visa karta)
413 46 GÖTEBORG
Arbetsplats Takara Bio Europe Swedish Filial
Kontakt Anna Gunnerling
anna_gunnerling@takarabio.com 0765250961 Jobbnummer 7635879
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