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Quality Assurance Executive

Olympus Medical Systems Vietnam CO., Ltd

Địa điểm làm việc: Hà Nội
Hết hạn: 01/06/2026
Thu nhập: Thương lượng
Loại hình: Toàn thời gian
Chức vụ: Nhân viên
Kinh nghiệm: 3 - 5 năm

Mô tả công việc

OLYMPUS MEDICAL SYSTEMS VIETNAM CO., LTD is a subsidiary of OLYMPUS CORPORATION, one of the leading Japanese corporations in the medical field. Along with our business expansion in Vietnam, we are looking for suitable, qualified candidates for the following position at our office in Hanoi City.
Job Title: Senior Quality Assurance Executive
Quantity: 01
Hanoi Office: V-Tower, 649 Kim Ma, Giang Vo Ward, Ha Noi
Job Summary:
This position is responsible for ensuring that the site's Quality Management System (QMS) is compliant with company policies/global Quality Standards/Global SOPs/etc, Regulatory requirements, and applicable Standards. The role involves managing quality-related processes, handling non-conformance & Corrective/Preventive Action activities, supporting audits, and leading/coordinating cross-functional continuous improvements.
Main Responsibilities:
1. Nonconformance (NC) / Corrective Action and Preventive Action (CAPA)
• Receive, assess, and coordinate non-conformances (NCs) arising from after-sales activities, including logistics, inbound/outbound operations, incoming inspection, and internal processes.
• Establish, implement, and monitor the effectiveness of Corrective and Preventive Actions (CAPA).
• Ensure all NCs and CAPAs are closed on time, supported by adequate evidence, and fully compliant with QMS requirements.
• Collaborate with cross-functional teams (e.g., Supply Chain, Warehouse) to ensure timely and effective resolution of NCs.
• Prepare periodic reports on NC/CAPA trends, including trend analysis and identification of recurring issues.
• Proficiency with Root Cause Analysis (RCA) tools such as 5 Whys, Fishbone (Ishikawa) diagrams or other structured problem-solving methodologies.
• Skilled at facilitating cross-functional RCA sessions.
2. Distribution Quality Management
• Evaluate, coordinate, and ensure that all warehousing, transportation, and distribution activities comply with applicable quality requirements (GDP, ISO, and internal standards).
• Monitor and control storage and transportation conditions (e.g., temperature, humidity, packaging integrity).
• Assess and oversee the performance and quality compliance of logistics service providers (3PLs).
• Investigate and manage distribution-related incidents, including product damage, loss, and environmental excursions.
• Participate in the development and continuous improvement of SOPs related to Distribution Quality.
• Ensure full traceability across the supply chain in accordance with regulatory and company requirements.
3. Ship Hold
• Coordinate with relevant departments to ensure effective communication, documentation, and control of affected products, while interfacing with global teams to support ship hold activities and clarify requirements.
• Prevent distribution of non-compliant products and ensure compliance with quality, safety, and regulatory requirements.
4. Others
• Lead/support cross-functional quality activities and continuous improvement initiatives.
• Knowledge of applicable regulations and standards, such as ISO 9001 / ISO 13485.
• Experience with audit and inspection readiness; able to defend CAPAs & NCs and demonstrate robust closure.
• Perform other tasks and responsibilities as assigned by the line manager as and when required.

Yêu cầu

Education:
• Bachelor of Science or Bio-medical Engineering preferred
Experience:
• 3-5+ years in Quality function, with proven experience in leading CAPA/NC and/or quality management system in an international organization dealing with Medical Device/Equipment/Pharmaceuticals.
Skills:
• Fluency in written and spoken English is mandatory. Writing: reports, emails, NC/CAPA documentation and Speaking: meetings and stakeholder communication.
• Strong analytical and problem-solving skills with attention to detail.
• Good communication and teamwork skills, with the ability to work independently, stay organized, and manage multiple tasks effectively.
• Facilitate cross-functional "lessons learned" sessions to enhance record quality.
• Partner with other sites and the Region/Global CAPA/NC CoE to identify and address systemic or recurring issues.
• Builds accountability across teams and drives timely CAPA & NC closure.
• Able to influence behaviours and culture around continuous improvement.
• Skilled in coaching others on CAPA & NC principles and data-driven decision making.
• Guide/coach investigators and approvers to strengthen analytical and systemic thinking capabilities.
• Promote best practices and continuous learning.
• Proficient in tracking CAPA timelines, deliverables, and metrics.
• Ability to manage multiple NC/CAPAs concurrently and prioritize based on risk.
• Demonstrate core values: Patient Focus, Integrity, Innovation, Impact, and Empathy.
Benefits:
• Competitive salary and comprehensive benefits package (including gasoline and telephone allowances, healthcare insurance package, and annual health check-up).
• Flexible working hours and hybrid working model (Work from Home).
• Opportunity to work in an international and professional environment with exposure to global standards and practices.
• Clear career development path with opportunities for growth and continuous learning.
• Training and development programs to enhance both technical and soft skills.
Interested candidates are kindly requested to send application and English CV with recent photo, copies of diplomas/certificates and any others that proof your educational background, to the Joboko Webpage.
(Qualified candidates will only be contacted for interview. Applications will not be returned.)
By submitting an application for this job position, you acknowledge and agree that you accept the practices, requirements, and/or policies outlined in this Privacy Policy.
Olympus Medical Systems Vietnam Co., Ltd. / Olympus Vietnam Co.. Ltd. respects your privacy. When you apply for a job at Olympus, Olympus will collect your personal data such as your name, contact details and employment history, and information included in your CV. By sending us your application, you agree to Olympus processing this personal data by automated or non-automated means to manage and assess your application and contact you about your application ("Processing Purpose"). If your application is unsuccessful, Olympus will securely dispose of your CV and other personal information, unless required to keep it for regulatory or audit purposes. Please help us protect your personal data by not including photographs or sensitive personal data in your application. We may share personal data with affiliates, service providers, business partners, suppliers, regulatory authorities and potential merger or acquisition parties or as required by law. Personal data may be transferred within or outside of Vietnam and processed from a place outside of Vietnam for the Processing Purpose. These other jurisdictions may have privacy regulations which are less protective than Vietnam. You can find more information about our privacy program, including your rights and obligations and how to contact us here: [protected info]
"We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply."

Quyền lợi

Thưởng
Competitive salary and monthly gasoline allowances
Chăm sóc sức khoẻ
Health Care Insurance Package, Annual Health Checkup
Hoạt động nhóm
Team-building activities, events

Thông tin khác

NGÀY ĐĂNG
29/04/2026
CẤP BẬC
Nhân viên
NGÀNH NGHỀ
Sản Xuất > Đảm Bảo Chất Lượng/Kiểm Soát Chất Lượng/Quản Lý Chất Lượng
KỸ NĂNG
Quality Control, Quality Assurance, QA, Biomedical, English
LĨNH VỰC
Thiết bị y tế
NGÔN NGỮ TRÌNH BÀY HỒ SƠ
Bất kỳ
SỐ NĂM KINH NGHIỆM TỐI THIỂU
3
QUỐC TỊCH
Không hiển thị
Xem thêm

Thông tin chung

  • Thu nhập: Thương lượng

Nơi làm việc

  • P305-307, Lầu 3, V-Tower, 649 Kim Mã, P. Giảng Võ, Hà Nội.

Cách thức ứng tuyển

Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Ứng tuyển bên dưới:
Hạn nộp: 01/06/2026
Giới thiệu công ty Xem trang công ty
Công ty chưa cập nhật thông tin....
Quy mô công ty
Từ 26 - 100 nhân viên

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Olympus Medical Systems Vietnam CO., Ltd
Địa chỉ công ty: 2nd Floor, Tan Da Court, 86 Tan Da, Ward 11, Dist.5,HCMC

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