Senior Quality Analyst - Complaints & Clinical Risk

Clinisys; Horsell; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

Clinisys is seeking a Complaints & Clinical Risk Quality Analyst to investigate and trend customer complaints, clinical safety issues, and product risks across Clinisys portfolios. The role supports regulatory compliance, post‑market surveillance, and continuous improvement in patient safety and product quality.

You will work with cross‑functional teams, applying risk management principles and CAPA methodologies, with exposure to QMS and SaMD environments.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, Biomedical Engineering, Clinical Laboratory Science, Quality, Regulatory Affairs, IT, or 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 with DCB0129 (preferred) and/or DCB0160.
• Experience investigating customer complaints, incidents, adverse events, and product quality issues.

Responsibilities

• Manage complaint handling throughout the lifecycle (intake, triage, investigation, root cause analysis, corrective actions, closure).
• Support post‑market surveillance through analysis of complaint, service, customer feedback, and product performance data.
• Participate in clinical risk management activities (hazard ID, risk assessment/evaluation, verification of risk control).
• Collaborate with Clinical Safety Officers, Product Management, R&D, and Customer Support to investigate complex issues.
• Utilize AI‑enabled tools and data analytics to improve trending, signal detection, and recurring issue identification.

Skills

Quality management

Risk assessment

Post‑market surveillance

Regulatory affairs

CAPA

Root cause analysis

Data analysis

AI tools

Education

Bachelor's degree in Life Sciences or related

Tools

eQMS

CAPA systems

LIS

LIMS

Data analytics platforms

Job description

Clinisys is seeking a Complaints & Clinical Risk Quality Analyst to investigate and trend customer complaints, clinical safety issues, and product risks across Clinisys portfolios. The role supports regulatory compliance, post‑market surveillance, and continuous improvement in patient safety and product quality.

You will work with cross‑functional teams, applying risk management principles and CAPA methodologies, with exposure to QMS and SaMD environments.