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Quality Assurance Specialist

2 weeks ago

Kuala Lumpur, Kuala Lumpur, Malaysia Randstad (Schweiz) AG Full time

We are seeking a detail-oriented and experienced Quality Assurance Specialist to join our medical team in Kuala Lumpur. The ideal candidate will possess strong analytical skills and a solid understanding of quality assurance processes in the healthcare sector, ensuring that all products meet the highest standards of safety and efficacy.

Job Description:
  • 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 coordinators for the region
  • Collect Quality data for Quarterly reviews
  • Maintain and track FCAs in countries working with country QA
  • Act as change author
  • Regulatory Compliance
  • Manage and track open Regulatory requirements implementation in countries
Key Responsibilities:
  • Bachelor's degree in related field required. 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
  • Excellent written and verbal communication skills in English
  • Strong problem-solving and critical thinking skills
  • Familiarity with Edwards policies, procedures, and guidelines relevant to quality systems
  • Knowledge of medical or pharmaceutical regulations as relating to documentation (e.g. Good Documentation Practices)
  • Understanding of medical devices regulations (e.g., ISO13485, Local Regulatory Requirements)
  • Attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment