Quality Compliance Specialist | Pasir Gudang

Company Background :

A global medical technology company specializing in innovative noninvasive monitoring solutions and advanced healthcare technologies. The organization is committed to improving patient outcomes and reducing the cost of care by developing cutting-edge devices and systems used in hospitals, clinics, and homecare settings. With operations in Malaysia, it supports engineering, manufacturing, and R&D activities, adhering strictly to international standards.

Duties & Responsibilities :

1. Investigate complaints daily :

• Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.
• Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
• Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
• Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
• Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
• Requests information from the customer related to complaint including the return of product(s) that are part of a system (i.e. sensor-cable-monitor).
• Review QPM trends related to complaints for potential trend.
• Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
• Evaluates each complaint if an investigation is required or not. Where investigation is needed, determine timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and timely completion of reports. Reviews complaint investigation reports to ensure investigations are thorough and adequate and in accordance with procedures.
• Executes duties in compliance with established company policies.
• Develops a thorough understanding of the complaint database.
• Perform other duties or special projects as assigned.

Job Qualifications :

Skills required :

Compulsory Requirement :