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)
- Robust 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).

📌 Quality Professional - Complaint Handling (India)
🏢 Siemens Healthineers
📍 India