Engineer (QA/QC and Standardization)

ABOUT VINUNIVERSITY
VinUniversity (VinUni) is Vietnam’s first private, not-for-profit university established to international standards, with the vision of becoming one of the world’s top 100 universities. Guided by its core values (EXCEL) of Empathy, Creativity, Leadership Mindset, Exceptional Capability, and Entrepreneurial Spirit, VinUni develops talent equipped to create meaningful impact in Vietnam and globally.
Founded by Vingroup, one of Asia’s largest private conglomerates, VinUni benefits from a dynamic ecosystem spanning Industrials & Technology, Real Estate & Services, Infrastructure, Green Energy, Culture, and Social Enterprises. This ecosystem provides unique opportunities for collaboration and innovation through leading organizations such as VinFast, Vinpearl, Vinmec, Vinschool, and Vinhomes, as well as a vibrant entrepreneurial network including VinVentures, VinMotion, VinRobotics, VinSpace, and VinEnergo, etc.
VinUni comprises four colleges: the College of Arts and Sciences, the College of Business and Management, the College of Engineering and Computer Science, and the College of Health Sciences. The University has established strategic partnerships with Cornell University, the University of Pennsylvania and Nanyang Technological University to advance excellence in education, research, and innovation.
In 2024, VinUni became the youngest and fastest university globally to achieve QS 5 Stars, earning the highest rating in nine categories: Global Engagement, Good Governance, Program Strength, Academic Development, Teaching, Employability, Facilities, Arts, and Social Impact. The University was also appointed by UNESCO as the first and only UNESCO Chair University, focusing on Environmental Leadership, Cultural Heritage, and Biodiversity.
As a rapidly growing research-intensive university, VinUni is investing in world-class talent, research centers, and cutting-edge facilities to drive breakthroughs in Artificial Intelligence and Machine Learning, Data Science, Environmental Intelligence, Innovations in Health Sciences, Policy Development, and Sustainable Societies.

ABOUT THE POSITION
The Institute of 3D Technology in Medicine (VI3D) is being established at VinUniversity on the foundation of the VinUni 3D Technology in Medicine Center (3D Lab), working closely with Vinmec Healthcare System. Since 2022 the 3D Lab has delivered more than 1,300 personalized cases for 18 hospitals, including patient-specific surgical instruments, anatomical models, cranial implant molds and customized titanium implants, under a quality management system certified to ISO 9001 and ISO 13485. 3D technology in medicine is listed among Vietnam's national strategic technologies, and VI3D is set to deliver national strategic technology tasks on personalized 3D-printed medical devices under the Ministry of Health for 2026–2030, spanning design, polymer and metal additive manufacturing, clinical trials, national standards and commercialization.
Reporting to the Chief Operating Officer, who concurrently heads the Operations, Quality and Product Department, the Engineer establishes and operates quality control, SOPs, traceability, product files and standardization for VI3D's medical 3D products.
The Engineer translates the requirements of institutional standards, TCVN, the ISO 13485 quality management system and relevant ISO/ASTM standards into checklists, forms, QC records, technical files and auditable evidence.
KEY RESPONSIBILITIES

• QMS documentation: Maintain procedures, work instructions, forms, and document and record control under ISO 13485 and ISO 9001.

• Inspection: Define and perform incoming inspection of powders, resins and materials, in-process inspection and final inspection, including dimensional checks, visual inspection and 3D scan deviation analysis.

• Traceability: Keep batch and build records that trace each product from case to material lot, machine, build, post-processing, QC, sterilization and delivery.

• Nonconformity and CAPA: Handle nonconformities, deviations and complaints; lead root cause analysis and corrective and preventive actions.

• Risk management: Maintain risk management files under ISO 14971 with the design and production teams.

• Audits: Conduct internal audits and prepare for certification body audits and regulatory inspections.

• Equipment and validation: Maintain calibration and maintenance records; support process validation (IQ/OQ/PQ) of printers, post-processing and cleaning.

• Standards and technical files: Compile requirements from ISO/ASTM standards (e.g., ISO/ASTM 52904, ASTM F3001, ISO 10993) and support drafting of TCVN, institutional standards and technical files for registration.

• Training: Train staff on SOPs and quality requirements.
  KEY SELECTION CRITERIA

• EDUCATION AND EXPERIENCE

• Bachelor's degree in Mechanical, Materials, Biomedical or Quality Engineering or a related field; a Master's degree is an advantage.

• Zero to two (0–2) years of experience in QA/QC or quality systems; fresh graduates with a strong academic record will be considered.

• ISO 13485 internal auditor certificate is an advantage, or willingness to obtain one within six (6) months.

• KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of ISO 13485 and ISO 14971; basic GMP practice.

• Measurement and metrology (calipers, CMM, 3D scanning); basic statistical process control.

• Ability to read technical standards in English.

• Systematic, rigorous and comfortable saying no when evidence is missing.

• Alignment with VinUni’s core values (EXCEL): Empathy, Exceptional Capability, Creativity, Entrepreneurial Spirit, and Leadership Mindset
  COMPENSATION & BENEFITS
  The salary and benefits are competitive and commensurate with qualifications and experience.
  We thank all applicants for their interest.
  Please note that only those candidates selected for interviews will be contacted.