Building an AI-First Organisation

Building an AI-first organisation is central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI-enabled, cloud-based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function—to work confidently with AI-enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve. Clinisys must drive an AI-first sense of purpose and urgency.

Clinisys has built an unrivalled reputation for deploying complex diagnostic networks and academic centres—and is the only provider to repetitively deliver to all disciplines end-to-end—at scale. Fostering healthier communities.

Purpose

The Complaints & Clinical Risk Quality Analyst is responsible for the investigation, analysis, trending, and resolution of customer complaints, clinical safety issues, and product-related risks across the Clinisys product portfolio. The role supports complaint handling, post-market surveillance, and clinical risk management activities to ensure compliance with applicable regulatory requirements while driving improvements in patient safety, product quality, and risk management practices.

Key Responsibilities

• Manage complaints throughout the full lifecycle, including intake, triage, investigation, documentation, and closure.
• Assess complaints for severity, clinical impact, patient safety implications, and regulatory reporting requirements.
• Conduct complaint investigations and facilitate root cause analysis and corrective actions.
• Support post-market surveillance activities through analysis of complaint, service, customer feedback, and product performance data.
• Participate in clinical risk management activities, including hazard identification, risk assessment, risk evaluation, and verification of risk controls.
• Maintain product hazard logs and risk management documentation in accordance with applicable regulations and standards.
• Assess incidents and complaints for vigilance and adverse event reporting requirements.
• Utilize data analytics and AI-enabled tools to support complaint trending, signal detection, and identification of recurring issues.
• Present investigation findings, risk assessments, trends, and recommendations to key stakeholders.
• Ensure complaint, safety, and risk management records are complete, accurate, and audit-ready within electronic quality management systems.
• Support internal audits, external audits, customer assessments, regulatory inspections, and continuous improvement initiatives.