Mô tả công việc
Position Summary:
Nextern, a 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 passionate about 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 is not limited to, PLM Administration, Record control, Training, and Pre‑shipment inspection management.
Job Description:
- Assist in developing and implementing standards and procedures.
- PLM Administration (CO, SCN, NC, CAPA, etc.).
- Scan, file, retain, and control documents and quality records following Quality System requirements.
- Assist in completing internal audit and external audit.
- Contact outside services, coordinate with other departments, and assist in completing registration records according to Vietnam regulatory requirements.
- 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.).
- Manage pre‑shipment inspection activities and ensure records are accurate and ready for each shipment.
- Administer onboarding training and monitor assigned training.
- Perform other assignments as requested.
Knowledge and Skills
- Problem Solving – The ability to identify problems and develop and implement solutions to the issues.
- Communication Skills – The ability to effectively communicate ideas, arguments, solutions, and work through conflict resolution at all levels of organizations, both internally and externally.
- Ethics – Consistently uses good judgment when analyzing right and wrong and performs at a level of conduct that is in line with corporate ethics guidelines.
- Hard work, enthusiasm, logical thinking, and good communication.
- Good administrative, document controlling, and organizational skills.
Qualification
- College degree or related field.
- At least one year of experience in a project administrative assistant, document controlling, or coordinator role.
- Computer skills: Proficient in Excel, Word, and MS Office/PC applications.
- English skills: Ability to read and understand specialized English documents.
- Experience in ISO and/or medical device industry would be an advantage.
- Be detail‑oriented, dependable, and trustworthy, as this position comes in contact with complex and sensitive documents.
Benefits
- Competitive salary
- Professional and friendly working environment, chance to attend employee training and development programs
- Premium healthcare insurance (in Vietnam) & business travel insurance, health, social, and unemployment insurance (following government regulation)
- Company trip, New Year party, team building
- Occasion‑based offerings: birthday, New Year, Mid‑Autumn, Labor Day, etc.