HIRING: Quality Assurance Specialist


Quality Assurance Specialist


Job Description

  • To understand companies’ (client) background and products for the setting up of ISO 13485 or relevant quality system processes.

  • Setup documentations (Quality Manual, SOPs, Protocols, Instructions, Forms and etc.) specific to the companies.

  • Provide ISO 13485 and ISO 14971 training for the companies.

  • Perform internal/supplier audits on companies and its contractors.

  • Provide support and advice to companies regarding document control, procedures and regulatory compliance.



  • At least a Diploma or Degree, preferably in Biomedical Science, Biomedical Engineering, Life Sciences or relevant field.

  • At least 1 to 2 years experience in a QA or RA role handling medical device and/or software is preferred.

  • Preferably with ISO 13485 and/or QSR audit experience.

  • Fresh graduates are welcome.



  • Open-mindedness towards challenges in a startup environment.

  • A good communicator and team player.

  • Meticulous and pay attention to details.

  • Able to manage multiple projects at one time.


Interested applicants: Please send in your updated CV to jason(at)yengandleong.com.