Quality Admin

Mô tả Công việc
Position Summary:
Nextern, an US based innovator in developing and manufacturing class II & III electro-mechanical medical devices is seeking a Document Control Specialist for its Ho Chi Minh city, Vietnam location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.
Quality Admin is responsible for controlling internal quality documents, external documents and quality records according to company quality procedure documents. The role will include but not be limited to PLM Administration, Record control, Training and Pre-shipment inspection management.
Job Description:
1. Assist in developing and implementing standards and procedures.
2. PLM Administration (CO, SCN, NC, CAPA, etc.)
3. Scan, file, retain and control documents and quality records following Quality System requirements.
4. Assist in completing internal audit and external audit.
5. Contact outside services, coordination with other departments. Assist to complete registration records according to Vietnam regulatory requirements.
6. Monitor data quality metrics, coordinate the processing of data issues, and propose solutions to improve data quality (monthly KPI, weekly review of quality events, etc.).
7. Manage pre-shipment inspection activities and ensure records are accurate and ready for each shipment.
8. Administer onboarding training and monitor assigned training.
9. Perform other assignments as requested.