Quality Management System Executive

ABIORES PTE. LTD.

Singapore
Not specified
Iso 13485 compliance implementation
Hsa regulatory requirements knowledge
Internal and external audit management
ABIORES PTE. LTD. is seeking a Quality Management System Executive in Singapore to develop and maintain their Quality Management System in compliance with relevant regulations. The ideal candidate will have experience in quality management within the medical device or IVD industry, with a strong understanding of regulatory requirements

Job Summary

  • The role involves developing and maintaining a Quality Management System compliant with ISO 13485 and GDPMDS regulations.
  • Candidates will manage documentation processes and lead preparation for internal and external regulatory audits.
  • The position requires investigating non-conformances and implementing corrective actions to ensure product quality.

Matching Summary

Match Score: 85

ABIORES PTE. LTD. is seeking a Quality Management System Executive in Singapore to develop and maintain their Quality Management System in compliance with relevant regulations. The ideal candidate will have experience in quality management within the medical device or IVD industry, with a strong understanding of regulatory requirements.

Skills & Requirements

Must-have

  • ISO 13485 compliance implementation
  • HSA regulatory requirements knowledge
  • Internal and external audit management
  • CAPA investigation and monitoring
  • Supplier audit support

Nice-to-have

  • Process improvement identification
  • Effective communication abilities
  • Independent task management

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • Minimum 2 years experience in medical device quality
  • Familiarity with EU IVDR and FDA QSR standards
  • Preferred ISO 13485 Lead Auditor certification

Work Rights

Not specified

Tailored Resume

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