Operations QA Lead at Neko Health

Mission Neko Health exists to shift healthcare from treating illness to preventing it, using advanced, non‑invasive technology and clinical expertise to deliver early, actionable health insights. Role Purpose Quality Operations at Neko is not box-ticking compliance — it is the infrastructure that makes world-class preventive healthcare possible at scale. As an Operations QA Lead, you will take ownership of the processes that keep our Quality Management System accurate, auditable, and continuously improving. You will drive the shift from reactive to proactive quality operations: turning data into trends, trends into decisions, and decisions into better outcomes for the people who use our technology. What You'll Deliver in the First 6–12 Months - 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. Minimum Qualifications - 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. Preferred - Experience with complaint handling and post-market surveillance workflows. - Familiarity with competence and training management in a regulated setting. - Experience conducting or supporting supplier audits. - Exposure to eQMS platforms and an interest in optimising digital QMS workflows. - Experience with AI/ML-assisted quality tools or automated process improvements. About titles at Neko We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process. Hiring Process Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team. Equal Opportunity & Inclusion Statement Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.