Quality Professional - Complaint Handling

Siemens Mobility

Bengaluru

On-site

INR 900,000 - 1,300,000

Full time

5 days ago
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Job summary

Siemens Healthineers in Bengaluru is seeking a Quality Professional - Complaint Handling to manage customer complaints related to CT medical devices. You will conduct systematic analyses, collaborate with cross-functional teams, and ensure regulatory reporting where required.

Ideal candidates have a engineering or life sciences background, 3–8 years of experience in medical device quality, and strong communication skills to work with international teams.

Qualifications

  • Bachelor’s degree in engineering, Life Sciences, or related field.
  • 3–8 years experience in complaint handling and quality management in medical devices.
  • Experience with SaMD, medical device reporting, and Post Market Surveillance

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.

Skills

Analytical skills
Communication skills
Teamwork

Education

Bachelor’s degree in engineering, Life Sciences, or related field

Job description

Quality Professional - Complaint Handling

519670

27-Ago-2026

Siemens Healthineers

Quality Management

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
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