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.

Required Skills & Experience

• Bachelor's degree in Life Sciences, Healthcare, Nursing, Biomedical Engineering, Clinical Laboratory Science, Quality, Regulatory Affairs, Information Technology, or a related discipline.
• 4-7 years' experience in Quality, Clinical Safety, Complaint Handling, Post-Market Surveillance, Regulatory Affairs, or Risk Management within a regulated industry.
• Minimum 5 years' experience working with DCB0129 (preferred) and/or DCB0160.
• Experience investigating customer complaints, incidents, adverse events, and product quality issues.
• Experience applying risk management principles in accordance with ISO 14971 or equivalent risk management frameworks.
• Experience with CAPA processes, root cause analysis methodologies, and effectiveness verification activities.
• Working knowledge of UK MDR, EU MDR/IVDR, FDA 21 CFR Part 820/QMSR, and ISO 13485.
• Experience supporting medical devices, diagnostics, healthcare software, laboratory systems, or Software as a Medical Device (SaMD) products.

Preferred Skills & Experience

• Experience with electronic Quality Management Systems (eQMS), complaint management systems, risk management tools, and data analysis platforms.
• Experience using AI-enabled tools to support complaint trending, signal detection, and investigation activities.
• Experience with Laboratory Information Systems (LIS) or Laboratory Information Management Systems (LIMS).
• Knowledge of statistical analysis and trend monitoring methodologies.
• Experience supporting internal audits, external audits, customer assessments, or regulatory inspections.
• Experience across the full product lifecycle, including development, post-market surveillance, complaint handling, and risk management.

This role requires a working knowledge of Artificial Intelligence (AI) technologies and the ability to leverage them to improve processes and outcomes. A core understanding of AI concepts is required and must be able to demonstrate the use of AI tools in a professional setting.

Onboarding
As part of our onboarding process, all new employees will be required to attend / travel to the office on their first day of employment. This requirement is essential for onboarding activities, including the identity verification, completion of necessary documentation, receiving your IT equipment, introductions to key team members, and orientation to Clinisys policies and procedures.

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