Quality Professional - Complaint Handling

Siemens Healthineers; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Siemens Healthineers in Bengaluru seeks a skilled professional to manage complaint handling for CT medical devices. You will analyze investigations, assess regulatory reportability, and monitor trends to drive safety improvements.

The role requires 3–8 years in medical device quality, strong communication, and experience with regulatory standards (FDA, EU MDR). International collaboration is a key aspect of the position.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related field.
• 3–8 years of experience in complaint handling and quality management for medical devices.
• Expertise in Complaint handling, Investigation, and Medical Device Reporting.
• Advanced understanding of clinical environments and healthcare IT standards (DICOM, HL7, IHE).
• Strong analytical skills and knowledge of global regulatory reporting (FDA, EU MDR).
• Excellent written and verbal communication; fluent in English.
• Ability to work in an international team environment.

Responsibilities

• Process customer complaints for CT medical devices per internal quality and regulatory requirements.
• Conduct systematic analysis of complaints and coordinate with cross-functional teams to resolve.
• Assess reportability to global regulatory authorities (FDA, EU MDR).
• Monitor complaint trends and provide insights for product safety improvements.
• Support risk management related to safety issues in complaints.
• Maintain complaint records and screening of service tickets.
• Support audits/inspections and process improvements.

Skills

Complaint handling

Quality management

SaMD experience

Regulatory reporting

DICOM

HL7

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in engineering or Life Sciences

Tools

DICOM

HL7

IHE

Job description

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).