Job Description

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.

Requirements

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.

Benefits

1. Benefits Competitive salary
2. Professional and Friendly Working Environment, chance to attend employee's training and development programs
3. Premium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation)
4. Company trip, New Year party, Team building
5. Occasion-based offerings: Birthday, New year, Mid-Autumn, Labor Day, etc.