Medical Device Complaints & Root-Cause Investigator

Becton, Dickinson and Company; Winnersh; On-site; GBP 33,000 - 51,000; Full time

Job summary

BD (Becton, Dickinson and Company) is seeking a Complaints Investigation Engineer in Winnersh, UK. You will evaluate, investigate, and resolve customer complaints related to medical devices, performing root-cause analyses and CAPA recommendations while ensuring regulatory compliance.

You will collaborate with Engineering, Manufacturing, Quality, Regulatory Affairs and Service teams to drive timely resolutions, document findings, and support continuous product improvement in a fast-paced

Qualifications

• Experience conducting technical investigations and failure analyses.
• Knowledge of complaint handling in regulated medical device environments.
• Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820.
• Excellent attention to detail and analytical problem solving.
• Strong written and verbal communication skills.

Responsibilities

• Manage receipt, assessment, processing, and evaluation of complaint-related devices and samples.
• Conduct investigations into customer-reported performance issues and adverse events.
• Perform technical troubleshooting and root-cause analyses of infusion systems and related devices.
• Document investigation activities, findings, and evidence in the complaint handling system.
• Analyse data and trends to identify recurring issues and opportunities for improvement.
• Support health hazard assessments and regulatory decision-making as required.
• Recommend and support CAPA implementation based on investigations.
• Collaborate with Engineering, Manufacturing, Quality, Regulatory Affairs and others to resolve issues.
• Ensure investigations are completed within timelines and regulatory requirements.
• Prepare investigation summaries and technical reports for stakeholders.
• Contribute to continuous improvement of complaint handling and customer experience.

Skills

Root Cause Analysis

Data Analysis

Technical Troubleshooting

Written & Verbal Communication

Cross-functional Collaboration

Education

Degree in Electronic, Mechanical, Biomedical Engineering or related discipline

Tools

Microsoft Excel

Job description

BD (Becton, Dickinson and Company) is seeking a Complaints Investigation Engineer in Winnersh, UK. You will evaluate, investigate, and resolve customer complaints related to medical devices, performing root-cause analyses and CAPA recommendations while ensuring regulatory compliance.

You will collaborate with Engineering, Manufacturing, Quality, Regulatory Affairs and Service teams to drive timely resolutions, document findings, and support continuous product improvement in a fast-paced