Quality Admin

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.