QA Associate Molecular Biology Tools

Quality Assurance Associate
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 molecular biology tools 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 in the European market, 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 production 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 molecular biology tool products assembled according to customer needs.
We are looking for a person with 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 of molecular biology tools at the site
Update our current QMS with adaptions to support our molecular diagnostics business (initially ISO9001, long term ISO13485)

Operation phase:
Manage QMS
Manage change controls and deviations and other processes supporting the production and monitoring trends
Manage, evaluate and qualify suppliers
Host/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 our new offer within molecular biology during the implementation and in later operation. 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 March 22, 2023 by applying through https://www.welcometothejungle.com/en/companies/takara-bio/jobs/qa-associate-molecular-biology_goteborg
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