Hoài Trịnh

Quality Assurance with experience in Japanese manufacturing environments, specializing in quality system management, document control, process change management, and audit coordination. Experienced in ISO 13485:2016 quality systems, SOP/document control, Change Control, internal audit activities, and external audit preparation including FDA and TÜV audits. Strong ability in cross-functional coordination, technical documentation handling, and maintaining compliance with company standards and regulatory requirements.

Currently working as ISO/QMS Leader with responsibilities in team supervision, quality system maintenance, audit preparation, and continuous improvement activities.

ISO/QMS Leader at NIKKISO VIETNAM (2026-01 – Present)

• Manage and maintain QMS documents including SOPs, procedures, standards, and quality manuals in compliance with ISO 13485 requirements and other regulatory requirements.
• Control document issuance, revision, distribution, and document storage compliance across departments.
• Prepare internal audit plans and support external audits conducted by TÜV and regulatory authorities.
• Maintain and improve QMS activities in compliance with company and regulatory requirements.
• Coordinate Change Control activities related to manufacturing processes, materials, equipment, and technical documentation.
• Report manufacturing-related changes to headquarters and issue internal communication regarding approved changes.
• Lead ISO/QMS team activities and coordinate with related departments regarding quality system and manufacturing changes.
• Train and support team members on document control and QMS compliance activities.

Quality Management Staff – ISO Team at NIKKISO VIETNAM (2023-02 – 2025-12)

• Maintain and revise QMS documents including SOPs, procedures, standards, and quality manuals in compliance with ISO 13485 requirements.
• Review technical drawings, specifications, and standards from headquarters and convert them into internal controlled documents.
• Control document issuance, revision, distribution, and document storage compliance across departments, including document patrol activities.
• Prepare annual internal audit plans and audit-related documentation.
• Support TÜV audits and participate in FDA inspection activities, including audit preparation and on-site support activities.
• Manage Change Control documentation related to manufacturing processes, raw materials, equipment, and technical documentation.
• Prepare evaluation reports and issue internal communication regarding approved changes related to new products, raw materials, and product quality.
• Report manufacturing-related changes to headquarters and coordinate related updates with departments.

Quality Assurance Intern at FPT TELECOM (2022-07 – 2022-12)

• Conducted field surveys and analyzed operational processes to identify improvement opportunities.
• Proposed process optimization solutions to improve operational effectiveness and service quality.
• Implemented process control activities to ensure compliance with company procedures and standards.
• Supported internal departments in resolving operational issues and process-related inquiries.
• Coordinated communication between departments during process improvement activities.

Bachelor's Degree in Business Administration - Quality Management – University of Economics Ho Chi Minh City (2019 – 2023)