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 the 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 full-time position. Elypta is located in Solna on the Karolinska Institute campus.

SUPERVISOR/MANAGER

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

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.

QUALIFICATIONS &SKILLS

Required

• 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 detail, with the ability to create clear and concise quality documentation and internal communication (Precision)
• Humbleness and open-mindedness towards different perspectives and ways of doing things (Humbleness)‍
• Ability to complete assigned actions with high quality in a timely manner (Performance)
• Ability to work independently as well as cross-functionally 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)

‍