- Maintain and improvement quality system according to ISO 9001, ISO 13485, GMP.
- Process Internal and external audit and follow up the NCR and CAR.
- Assistant QMR to preparing technical file for regulatory affair job.
- Manage and contact with third party laboratory for regular testing of product base on internal program & customer requirements.
- Risk analysis
- Organizing and controlling of documentation to ensure that appropriate and current as well as annual review of
external standard.
- Manage and contact with Thai FDA concerned company registration license, import license and
certificate of free sale / certificate of origin