Instrument Design QA Lead
Hybrid (Stockholm)Full-timePosted 6mo ago
About the role
QA lead responsible for ensuring safety, quality, and regulatory compliance of Neko’s medical device hardware and firmware across a dedicated product family (Skin, Heart, Tissue) from design inputs to design transfer, with emphasis on design controls, risk management, and continuous improvement.
Responsibilities
- Quality assure design controls across the product lifecycle, reviewing and approving verification and validation plans and results, and keeping design inputs, outputs and traceability coherent across the family.
Skills
Required:Design controls and risk managementRegulatory knowledge (EU MDR, FDA QMSR)Systems engineering mindsetQuality tooling and AI-assisted documentation
Nice to have:Audit and regulatory submissions
Last updated Oct 2, 2026. Interested? Apply on the company site.
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