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Quality Professional - Complaint Handling

職缺編號
512138
發布時間
30-六月-2026
工作領域
Quality Management
公司
Siemens Healthcare Private Limited
經驗等級
高級專業人士
工作职位
全職
工作模式
僅辦公室/ 工地
工作性質
長期
地點
  • 班加羅爾 - 卡納塔克邦 - 印度
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).