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Senior Quality Analyst

4 weeks ago

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

We're Hiring: Senior Quality Analyst - Medical Device

We are seeking a detail-oriented and experienced Senior Quality Analyst to hold a regional role responsible for Post Market Surveillance Analysis and Supplier Performance Reporting. He/She will maintain the quality management system to meet the company's requirements, relevant quality standards, and regulatory requirements.

Work Mode: Work From Office

Role: Senior Quality Analyst - Medical Device

What You'll Do:

  • Maintain the quality management system to meet the company's requirements, relevant quality standards, and regulatory requirements.
  • Responsible for Post Market Surveillance Analysis and Supplier Performance Reporting.
  • Supplier Performance Trending & Reporting for APAC.
  • IQVIA system Quality administrator for APAC.
  • Collate & Deep-dive analysis of APAC Post-Market Quality data trending for regular review with stakeholders and the leadership team.
  • Other incidental duties: Implement continuous improvement programs or projects assigned by the manager.

What We're Looking For:

  • Understanding of medical device regulations (e.g., ISO 13485, Local Regulatory Requirements).
  • Knowledge in medical or pharmaceutical regulations as related to documentation (e.g. Good Documentation Practices).
  • 3-5 years of previous related experience required, with at least 2 years in a medical device, healthcare, or related environment.
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