Hybrid Operations QA Lead

at Neko Health

• Job title: Operations QA Lead
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Stockholm, Sweden

About the role

• Operations QA Lead at Neko Health managing quality operations and driving improvements in preventive healthcare technology. Responsible for CAPA processes and enhancing quality systems.

Responsibilities

• Take full ownership of the NC and CAPA process — establishing consistent root cause analysis, closing outstanding actions, and building trending visibility so we catch systemic issues before they escalate.
• Move our quality operations from reactive to proactive: introduce trending and early-warning signals across complaints, NC, and supplier performance data.
• Increase organisational knowledge of NC and CAPA — run training and knowledge-transfer sessions so that cross-functional teams understand their role in quality processes and can act with confidence.
• Improve supplier management oversight: implement a structured evaluation cadence and clear escalation paths, resulting in measurable improvements in supplier performance tracking.
• Support at least one internal or Notified Body audit cycle, contributing to successful outcomes with no critical findings in your areas of ownership.
• Identify and implement at least two AI-assisted optimisations in quality workflows — whether in document control, complaint trending, or CAPA tracking — demonstrating how AI can improve speed and judgment without compromising rigour.

Requirements

• 2–3+ years of experience in Quality Operations or QMS management within a regulated industry (medical device, pharma, or healthtech preferred).
• Solid working knowledge of ISO 13485, EU MDR, and/or IVDR — you understand what these frameworks require in practice, not just on paper.
• Hands-on experience managing NC and CAPA processes, including root cause analysis and effective corrective action implementation.
• Experience in supplier quality management — monitoring, evaluations, and escalation handling.
• Relevant academic background (life sciences, engineering, or equivalent) or demonstrable equivalent experience.
• Clear, structured communicator — able to work cross-functionally and translate compliance requirements into practical guidance for non-QA teams.
• Strong judgment: knows when to apply rigour and when pragmatism serves quality better; comfortable making decisions in a fast-moving environment.

Benefits

• Health insurance
• Flexible working hours
• Professional development opportunities
• Inclusive hiring and support for adjustments in the hiring process