Job description

Job Role:
Supplier Management
-Maintenance/Control of existing Supplier
-Qualification new Supplier

Training Management
-Tracking of training for all employees for on time completion
-Drive all kind of improvement activities related to training

Quality Management System
-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.
-Act as Audit (Internal, external etc.) coordinators for the region
-Collect Quality data for Quarterly Management /other reviews
-Maintain and track FCAs in countries working with country QA
-Act as Ignite change author

Regulatory Compliance
-Manage and track all open Regulatory requirements implementation in countries

Job Requirements:
-Bachelor's degree in any field. Electrical Engineer degree is preferred.
-8-10 years of previous related experience required
-Experience working in a medical device, healthcare, or a related environment preferred
-Proven expertise in MS Office Suite
-Strong written and verbal communication skills in English
-Full knowledge of medical or pharmaceutical regulations as relating to documentation (e.g. -Good Documentation Practices)
-Full understanding of medical devices regulations (e.g., ISO13485, Local Regulatory Requirements)
-Location: KL Eco City

Job Type: Full-time

Salary: RM4,000.00 - RM6,000.00 per month

Benefits:

• Opportunities for promotion
• Professional development

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Quality control: 3 years (Preferred)

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