Elypta is a Swedish diagnostics company on a mission to improve early detection of cancer. Elypta is pioneering a metabolism-based liquid biopsy measuring the GAGome, a novel class of biomarkers of tumor metabolism. Algorithms are trained to detect signatures of cancer noninvasively in the blood or urine.

Elypta was named in the Ny Teknik 33-list of best start-ups in Sweden for three years. Among its many awards are the MIT Technology Review Under 35 list, the Nature Research Award for university spin-offs to watch, and the Roddenberry Prize. Elypta is backed by top venture capital firms including Industrifonden, Navigare Ventures, Bonnier Capital, Norrsken VC, and Nina Capital.

As Elypta advances, we expect the role and challenges we face to evolve, and we are therefore looking for a flexible candidate with a strong drive and motivation for personal development who wants to grow with Elypta.

Position background
Elypta is developing unique IVD kits for clinical mass spectrometry with in-house kit production and software development. Operations are ISO 13 485 certified and target future market approvals and commercial launch in North America as well as Europe. The QARA team needs to expand to handle the growing scope of Elypta’s activities. Elypta is nearing clinical validation and the first filing with FDA as well as notified body in Europe under IVDR.

Elypta is now seeking a QA Specialist who will support and drive QA activities in all areas of the company.

This is a fulltime position. Elypta is located in Solna on the Karolinska Institute campus.

The candidate will report to the VP of QARA.

Key responsibilities and activities

• Ensure and drive quality assurance work at Elypta, working closely with the teams - spanning R&D, software development, production and commercial activities
• Ensure on-going compliance with Elypta’s QMS and all applicable standards
• Work within Elypta’s eQMS system and support broader team in this environment
• Continuous improvement of the QMS and quality work at Elypta
• Drive continuous monitoring and process improvements
• Work with suppliers to ensure quality
• Support in organizing, leading and participating in internal and external audits and inspections
• Help develop and implement quality and regulatory strategic plans for supporting Research Use Only and In vitro Diagnostic devices
• Training activities
• Contribute to Elypta’s team culture based on safety, trust, performance, humbleness and precision

Required qualifications and skills

• MSc degree in any relevant discipline
• 1-3 years experience from medical device/ IVD development under ISO 13485

Personal characteristics
There are 5 key personal characteristics to fit well with Elypta’s culture:

• High attention to details, with the ability to create clear and concise quality documentation and internal communication (Precision)
• Humbleness and open-mindedness towards different perspectives and way of doing things (Humbleness)
• Ability to complete assigned actions with high quality on a timely manner (Performance)
• Ability to work independently as well as cross-functional and know when to seek help (Trust)
• Mindful about the needs of the team and of all stakeholders in Elypta, in particular the patients our tests seek to help (Safety)

For more information about this exciting role, please contact: 

Helene Rydberg Widahl, Senior Rekryteringskonsult at Rekryteringsspecialisten AB.

Contact details:
tel: 072-961 06 79
e-mail: widahl@rekryteringsspecialisten.se