AI-Enabled QA Engineering Lead for Medical Devices

Neko Health; Stockholms kommun; On-site; SEK 600,000 - 800,000; Full time

Job summary

Neko Health, located in Stockholms län, seeks a QA Engineering Lead to enhance quality assurance through AI. You will design and implement AI-driven quality systems, ensuring compliance while improving workflow efficiency.

Your responsibilities include developing AI tools for quality processes, establishing regulatory controls, and collaborating with teams to translate quality management procedures into automated workflows. Candidates must have substantial experience in QA within medical devices and strong communication skills.

Qualifications

• At least 5 years of experience in QA, RA, or Engineering within medical devices.
• Understanding of quality management systems in regulated environments.
• Experience with automation, tooling, and system integrations.

Responsibilities

• Build AI instruction and infrastructure layer for quality procedures.
• Establish controls for AI-enabled tools in a regulated environment.
• Translate QMS procedures into AI-assisted workflows.

Skills

QA experience

Regulatory Affairs knowledge

Systems Administration

QMS automation

Fluent in English

Tools

Python

PowerShell

Job description

Neko Health, located in Stockholms län, seeks a QA Engineering Lead to enhance quality assurance through AI. You will design and implement AI-driven quality systems, ensuring compliance while improving workflow efficiency.

Your responsibilities include developing AI tools for quality processes, establishing regulatory controls, and collaborating with teams to translate quality management procedures into automated workflows. Candidates must have substantial experience in QA within medical devices and strong communication skills.