Quality Professional - Complaint Handling

Job description

Responsibilities • Processing customer complaints related to CT 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. • 3-8 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).