Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases.
Resolves cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects.
Interface with Affiliates and assumes responsibility for timely communication of quality related information to the Country Organizations.
Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
Analyzes data using statistical measures for determining a potential product performance issue.
Responsible for escalating cases which cannot be directly resolved to appropriate levels and initiating further investigation and communicating case derived information as appropriate.
Ensures cases are compliant and conform to established quality processes, standards, and regulations.

You own a degree in bioinformatics, computational biology, biomedical engineering, computer science, or an IT related field.
Strong communication skills in English (written and spoken) are essential
Work experience in the area of Software related or bioinformatics and/or in support related functions is desired.
Experience reading source code
Understanding of cloud computing platforms as well as experience managing on premise infrastructure (including servers and high performance computing clusters) is desired.
You are able to read and or debug source code of different programming languages to understand the root cause of reported issues.

Complaint Handling Engineer – Medical Software

Key skills