Specialist - Quality - Healthcare

Role Purpose:

The Quality Specialist is responsible for maintenance of quality management system to meet our Clients requirements, relevant quality standard and regulatory requirements

Essential Job Functions

Quality Management System : - 40%

a) Work with cross-functional team on NCR, CAPA, and Product Risk Assessment (PRA) Process, including the required document preparation in a timely manner. Follow up CAPA and NCR action plan.

b) Collect Quality data for Quarterly Management /other reviews

Regulatory Compliance : 20%

a) Collect all new regulation announcement via RI platform, track all new regulations in SEA countries till implementation completion

b) Coordinate with EU CHU for all MDRs in SEA countries for timely submission

c) Translation of MDR in Thai for THFDA submission

Trouble shooting Center (TSC) QA support : 15%

a) Work closely with TSC engineer for implementation of all servicing related procedures

b) Support in Qualification/Validation of equipment

c) Review and approve Calibration reports

d) Product release activities

Supplier Management : 10%

a) Maintenance/Control of existing Supplier

b) Qualification new Supplier

Training Management : 10%

a) Tracking of training for all employees for on time completion

b) Manage the training needs for employees and work as country change leader

c) Drive all kind of improvement activities related to training

Marginal Job Functions : 5 %

Other incidental duties: Implement continuous improvement program or project assigned by manager