Quality Assurance

7 days ago


Singapore ABIORES PTE. LTD. Full time $80,000 - $120,000 per year

Job Description

  • Maintain and improve the Quality Management System (QMS) in line with ISO 13485, GDPMDS, and other relevant standards.
  • Ensure compliance with HSA regulations and other international requirements (e.g. EU IVDR, FDA QSR).
  • Prepare and manage regulatory submissions and product registrations for medical devices and IVD products.
  • Handle post-market activities, including product renewals, vigilance reporting, and change notifications.
  • Manage and update quality documents such as SOPs, work instructions, and forms.
  • Support and participate in internal and external audits, and follow up on corrective and preventive actions (CAPA).
  • Conduct training for staff on quality and regulatory topics.
  • Work with suppliers and internal teams to ensure products and processes meet quality and regulatory requirements.
  • Support continuous improvement of quality processes and compliance systems.

Job Requirements

  • Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
  • At least 2 years' experience in Quality Assurance or Regulatory Affairs in the medical device or IVD industry.
  • Knowledge of ISO 13485, GDPMDS, EU IVDR, FDA QSR, and HSA regulations.


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