الوصف الوظيفي
Position: Quality Professional - Complaint Handling
Responsibilities
• Processing customer complaints related to software medical devices according to internal quality requirements, legal requirements and international standards.
• Conduct a systematic analysis of complaints and collaborate with cross-functional teams to investigate and resolve them.
• Assess complaints to determine reportability to global regulatory authorities (e.g., FDA, EU MDR).
• Monitor complaint trends and provide insights for product improvement and safety related field actions.
• Provide support for risk management related to customer complaints, particularly those involving (potential) safety issues.
• Monitoring and reporting of complaint handling KPIs to management.
• Maintain accurate complaint records and perform service ticket screening.
• Support audits/inspections as needed.
• Support and implementation of process improvements as needed.
Required Knowledge/Skills, Education, and Experience
• Bachelor’s degree in engineering, Life Sciences, or related field.
• 3-7 years of overall experience in complaint handling, quality management in medical devices. Experience in SaMD is preferred.
• Expertise in Complaint handling, Complaint Investigation, Medical Device Reporting, Post Market Surveillance
• Advanced system knowledge in clinical environment as well as clinical workflows and healthcare related IT standards (e.g. DICOM, HL7, IHE is preferred)
• Strong analytical skills with knowledge of global regulatory reporting requirements (e.g., FDA, EU MDR).
• Excellent communication skills and attention to detail.
• Ability to work in an international team environment.
• Excellent written and verbal communication skills
• Fluent in English (written and spoken).
