Responsibilities
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Processing customer complaints related to CT medical devices according to internal quality requirements, legal requirements and international standards.
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Conduct a systematic analysis of complaints and collaborate with cross-functional teams to investigate and resolve them.
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Assess complaints to determine reportability to global regulatory authorities (e.g., FDA, EU MDR).
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Monitor complaint trends and provide insights for product improvement and safety related field actions.
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Provide support for risk management related to customer complaints, particularly those involving (potential) safety issues.
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Monitoring and reporting of complaint handling KPIs to management.
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Maintain accurate complaint records and perform service ticket screening.
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Support audits/inspections as needed.
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Support and implementation of process improvements as needed.
Required Knowledge/Skills, Education, and Experience
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Bachelor’s degree in engineering, Life Sciences, or related field.
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3-8 years of overall experience in complaint handling, quality management in medical devices. Experience in SaMD is preferred.
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Expertise in Complaint handling, Complaint Investigation, Medical Device Reporting, Post Market Surveillance
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Advanced system knowledge in clinical environment as well as clinical workflows and healthcare related IT standards (e.g. DICOM, HL7, IHE is preferred)
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Strong analytical skills with knowledge of global regulatory reporting requirements (e.g., FDA, EU MDR).
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Excellent communication skills and attention to detail.
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Ability to work in an international team environment.
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Excellent written and verbal communication skills
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Fluent in English (written and spoken).
