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

• 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