Main Responsibilities:
1. Make sure medical disposable as well as PPE suppliers comply to MDR or PPE regulations. Get involved and take initiative for new MDR/PPE suppliers approval process with HQ
2. Responsible for updating, elaborating as well as documentation for all new updates related to regulatory as well as compliance affairs
3. In charge of all AC as well as suppliers related audit including but not limited to ISO, FSC, BSCI, BEPI, Swam label and GRS…
4. Assist Abena China approved for medical as well as PPE products under our own company title without any difficulties.
5. Assist export manager to arrange QC schedule, follow up/co-ordinate with suppliers in case of any change or emergency case if needed
6. Draft up of specifications regarding medical products as well as testing protocols where needed together with LPMs.
7. Offer higher service level to both internal and external clients, proactively identify potential quality and compliance risks to warn suppliers as well as AC team.
8. Define, implement and execute effective Quality strategies and processes for Abena China to fit to HQ QA strategy.
9. Liaise outside labs or 3rd party or consultant service and work with them to help/assist Abena or Abena suppliers qualified for designated projects.
10. Other tasks assigned by Export Dept. Manager and GM.

Qualifications:
1. Bachelor’s degree or equivalent
2. Good written and spoken English, able to communicate or present ideas independently.
3. At least 3 years working experience in QA/QC field.
4. Familiar with the quality standards especially for EU MDR, ISO 13485, ISO 9001/14001.
5. Knowledge of social compliance audit including but not limited to BSCI, BEPI, Sadex 8000z…
6. Knowledge of FSC and GSR is preferred.
7. Passionate, detail and gold-oriented and able to work under pressure.