Quality Assurance Specialist
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.