Bachelor's degree in any field. Electrical Engineer degree is preferred.
8 to 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
Tanggungjawab
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
Manfaat
Will be discussed
Soal Jawab Jawatan
Tanya soalan dan majikan akan menjawab tentang jawatan ini
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