Thanh Nguyen

t.nguyennoSpam@axxos.noSpamch

  • Diploma in mechanical engineering
  • Bachelor degree in business processes
  • Master of advanced studies in quality leadership
  • Quality management qualifications)
    (Medical device regulation, CSV representative, ISO 13485, FDA)
  • ISO 13485:2016 auditor

Senior Consultant at Axxos GmbH since 2020

Experience

  • Over 7 years' experience in medical device industry in varioous job roles
  • Over 10 years' experience in quality management in various positions and industries
  • Over 3 years' managerial experience in variuous job roles
  • Responcible for quality management and regulatory compliance of medical devices for over 4 yeras (ISO, FDA)
  • Over 4 years' experience as a quality engineer working with medical devices and in the automotive, aviation, space and defence industry
  • Over 5 years' experience in production
  • Lead auditor for internal and external audits (ISO 13485, FDA and AIAG 16949)

Projects

  • Development and maintenance of QM-systems according ISO 9001 / 13485, MDD/MDR,  21CFR820 (FDA), part 11 (FDA)
  • Successful certification and recertification with various companies
  • Establish and implement validation concepts in MedTech and automotive companies
  • Audit and inspection readiness, compliance and guidance through NB Audits and FDA investigations
  • Internal and supplier auditing according ISO 9001, ISO 13485, FDA, and AIAG 16949 requirements
  • Implementation and maintenance of CAQ Systems incl. software validation
  • Computer system validation according part11 (FDA)
  • Implementation of Best Practices in CAPA, deviation management, audit and Inspection

Skills

  • Quality management practices
  • Validation of equipment, production, inspection processes
  • Computer software validation according GAMP 5
  • Pre and post audit activities in conjunction with notifed body audits and FDA inspections
  • Expert in manufacturing process
  • Quality system, process and supplier auditing
  • Intercultural communication

My personal scrabble - is in production