Quality Admin
Nextern
Quality Admin
Nextern
Designs and manufactures medical devices
Nextern · Ho Chi Minh City, Vietnam · Full-time · Posted 2026-10-09
Workplace: on_site
Department: Quality Systems
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.
Knowledge, And Skills
1. Problem Solving - The ability to identify problems and develop and implement solutions to the issues.
2. Communication Skills - The ability to effectively communicate ideas, arguments, solutions and work through conflict resolution at all levels of organizations both internally and externally.
3. Ethics - Consistently uses good judgment when analyzing right and wrong and performs at a level of conduct that is with corporate ethics guidelines.
4. Hard work, enthusiastic, logical thinking and good communication.
5. Good administrative, document controlling and organizational skills.
Qualification:
1. College’s degree or related field
2. Have at least a minimum of one year or above working experience in a project administrative assistant, document controlling or coordinator role.
3. Computer skill: Proficient in Excel, Word, and MS Office/PC applications.
4. English skills: Ability to read and understand specialized English documents
5. Experience in ISO and/ or medical device industry would be advantage
6. Be detail-oriented, dependable and trustworthy since this position come in contact with complex and sensitive documents.
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Nextern designs and manufactures medical devices for equipment makers, with engineering and factory teams involved from early prototypes through production. Its work includes catheter-based instruments and electronic systems used in minimally invasive treatment and diagnostic procedures. Customers pay for development and contract manufacturing services, with project costs shaped by device complexity, materials and production scale. Its clinical markets include vascular and heart interventions and nerve stimulation, with services sold separately or as an integrated program. Founded in 2000 with industrial engineering roots, Nextern shifted to medical devices in 2016 and is headquartered in Maple Grove, Minnesota.
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