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Siemens Healthcare

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4.4

based on 264 Reviews

30 Siemens Healthcare Jobs

Quality Professional - Complaint Handling

Siemens Healthcare

4.4

based on 264 Reviews

3-7 years

Bangalore / Bengaluru

1 vacancy

Quality Professional - Complaint Handling

Siemens Healthcare

posted 11hr ago

Job Role Insights

Flexible timing

Key skills for the job

Healthcare Life Sciences Risk Management Medical Devices SAP Quality Management Regulatory Reporting

+ 4 more

Job Description

Position: Quality Professional - Complaint Handling

Responsibilities

Processing customer complaints related to software 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.

3-7 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).

Employment Type: Full Time, Permanent

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