Senior Quality Management Specialist (medical Devices)
Kuala Lumpur, Malaysia
Job Description
- 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
Supplier Management
- Maintenance/Control of existing Supplier
- Qualification new Supplier
- Tracking of training for all employees for on time completion
- Drive all kind of improvement activities related to training
- 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
- Will be discussed
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Job Detail
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Job IdJD859741
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationKuala Lumpur, Malaysia
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EducationNot mentioned