Senior Quality Assurance Manager

2 weeks ago

Singapore beBeeQualitySystems Full time $90,000 - $120,000
Job Description

We are seeking a Quality Systems Specialist to support regional quality operations in the Asia Pacific region.

  • The ideal candidate will have experience in implementing and maintaining product inspection, release, labeling, and rework processes.
  • They will oversee quality holds, SCARs, and internal complaints, and perform First Article Inspections for products across Asia Pacific and Greater China.
  • The Quality Systems Specialist will also ensure compliance with company SOPs at 3PL locations and maintain and qualify suppliers.

Key Responsibilities:

  1. Implement and maintain product inspection, release, labeling, and rework processes
  2. Oversee quality holds (local & global), SCARs, and internal complaints
  3. Perform First Article Inspections (FAI) for products across Asia Pacific and Greater China
  4. Ensure compliance with company SOPs at 3PL locations
  5. Maintain and qualify suppliers
  6. Provide quality training and ensure supplier control measures are in place
  7. Manage product complaint handling, field corrective actions, and relevant reporting in APAC
  8. Coordinate with central complaint handling and JDE systems for sample tracking and documentation
  9. Generate quality reports and trend analysis
  10. Own and manage NCRs, CAPAs, and PRA activities
  11. Assess ECRs and contribute feedback for continuous improvement
  12. Participate in internal/external audits
  13. Maintain training records for compliance
Required Skills and Qualifications
  • Bachelor's Degree in a relevant field
  • Minimum 3 years of experience in quality or manufacturing, ideally in the medical device sector
  • Strong knowledge of ISO 13485, medical/pharma documentation, and quality systems

Benefits

We offer a competitive compensation package and opportunities for growth and development.

Others

Please click the link below to apply.

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