Key Job Purpose

To maintain and support the Quality Management System (QMS)

Primarily responsible for Document Control, Managing Change Assessments from RHQ, Warehouse operation monitoring and post-market surveillance & vigilance to ensure compliance with ISO 9001 and medical device regulations.

Support Corporate and other quality audit activities, assist in QMS administrative tasks such as Management Review and Risk Management, and coordinate quality-related activities across departments.

Summary Of Functional Duties & Responsibilities

Document Control:
Responsible for control, review, and maintain all quality system documentation to ensure strict alignment with ISO 9001 standards and Good Distribution Practice for Medical Devices (GDPMD).
Monitor, evaluate, and adopt Regional Quality Procedure (RQP) and related guidelines from the Regional Headquarters (RHQ) to develop and update local Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Change Assessment:
Responsible for monitoring notifications from RHQ and executing Change Assessments to internal organization. Support the internal Change Control process to ensure all modifications are documented
Post-Market Surveillance & Vigilance:
Responsible for executing Post-Market activities including disseminate Field Safety Corrective Actions, Field Corrective Actions, Product Notification from Legal Manufacturer to relevant parties both internal and business partner, Coordinate and follow-up the Acknowledgement Letter and required document until status close.
Monitoring Adverse Event alert from RHQ and coordinate with Regulatory Affairs personnel for reporting decision.
Quality Audits:
Support in planning, execution, and follow-up of internal audits, ensuring compliance with regulatory standards and company policies.
Support Corporate and External quality audits by coordinating audit activities, preparing documentation, and ensuring audit readiness
Administrative Support:
Assist in Management Review, Risk Management, and other required QMS elements for ISO 9001 and GDPMD, including coordinating team schedules and preparing relevant documentation.

Job Specification

Bachelor Degree of Science or equivalent.
Minimum 2 years of experience in Quality Assurance role or Quality Control in the Medical Devices or healthcare industry.
Knowledge of ISO 9001 and GDPMD (Good Distribution Practice for Medical Devices).
Certified Internal Auditor for ISO9001Proficiency in Document Control management.
Strong computer literacy (MS Office: Word, Excel, PowerPoint).
Good command in English (especially reading and writing for documentation)
Quality-Driven, Collaboration, Accountability
Experience within the Medical Device or IVD industry is preferred.Experience in CSV (Computerized System Validation)
Occasional travel to warehouse or for quality audit purposes.

Officer, Project Engineer

Document Control Officer

QA Officer