Siemens Healthcare BSc Life Science Job, Apply Online For Quality Professional Role
Quality Professional – Complaint Handling
Bengaluru, Karnataka, India
Job Description
Job ID: 447919
Company: Siemens Healthcare Private Limited
Organization: Siemens Healthineers
Job Family: Quality Management
Experience Level: Experienced Professional
Full Time / Part Time: Full-time
Contract Type: Permanent
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 environments 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).
Keywords: Siemens Healthcare, Quality Professional, Complaint Handling, Bengaluru, Karnataka, India. Siemens Healthcare BSc Life Science Job, Apply Online For Quality Professional Role. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
