MedTech Complaints Specialist & Quality Investigator

Cochlear Limited; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

Cochlear Malaysia is seeking a Complaints Specialist to manage the intake, evaluation and reporting of complaints in accordance with global processes. You will gather details from field staff, monitor progress and maintain records to ensure timely regulatory submissions.

Responsibilities include determining need for device investigations, documenting root causes and corrective actions, and training staff on complaints procedures to drive continuous improvement within the organization.

Qualifications

• Minimum Degree in Biomedical/Bioscience or relevant field.

Responsibilities

• Receive, evaluate and report complaints per Global Complaint Handling processes.
• Gather complaint details from Field staff to support investigations and MDR/Vigilance reporting.
• Monitor and progress complaints to ensure timely reporting and closure for regulatory compliance.
• Maintain accurate records and inform others when records change.
• Assess if a complaint requires a device investigation and document root cause/corrective actions.
• Provide support and training on complaints processes to Field staff and users.
• Identify improvements to complaints handling processes and interfacing procedures.

Skills

English communication

Regulatory awareness

Education

Biomedical/Bioscience degree

Job description

Cochlear Malaysia is seeking a Complaints Specialist to manage the intake, evaluation and reporting of complaints in accordance with global processes. You will gather details from field staff, monitor progress and maintain records to ensure timely regulatory submissions.

Responsibilities include determining need for device investigations, documenting root causes and corrective actions, and training staff on complaints procedures to drive continuous improvement within the organization.