(Senior) QMS Engineer - Medical Devices
Long An (On-site)
Nghỉ trọn T7, CN
Hạn chót 09/12/2026
Đăng 3 ngày trước
Ít hơn 20 ứng viên
Yêu cầu công việc
You are Expected:
- Assists QA manager for medical device quality system and regulatory management in manufacture process.
- Fluent in oral and written English. The communication capability of Chinese will be perfect.
- Quality system & regulation management background.
- Assesses, coaches, and monitors the developments of supplier.
- Ability to work independently.
- Be honest, loyal to the work.
- Strong code of ethics.
Education/Certifications/Affiliations:
- Bachelor's degree or above in Mechanical, Electrical, Electronic, Pharmaceutical or related fields.
- At least 5 years of experience in medical device production quality systems, familiar with ISO 13485 quality system and medical device regulatory requirements, with experience in quality managementsystem writing or implementation preferred.
- Familiar with medical device system ISO13485, FDA, QSR820, independent promotion of the establishment and certification of medical system is preferred.
Travel Requirements
- Be flexible for domestic and international travel.
Yêu cầu nên có
Chinese communication skills Experience writing or implementing quality management systems Familiarity with medical device systems, including ISO 13485, FDA, and QSR 820 Experience independently promoting the establishment and certification of a medical system
Công việc cụ thể là gì?
About the Role:
In this role, you will assists QA manager for medical device quality system and regulatory management in manufacture process, you will play a critical part in driving innovation, solving complex challenges, and delivering meaningful impact. This is an opportunity for someone who is curious, action-oriented, and motivated to push boundaries in a fast-paced environment.
This is where your SharkNinja journey begins. You’re an explorer—not a tour guide—driven by curiosity, fueled by taking chances, and unwilling to fly under the radar. Here, bold moves turn into real impact, growth comes from challenge, and your work helps shape what’s next.
LOCATION: Vietnam.
Here are some of the EXCITING things you’ll get to do:
- Responsible for implementing and improving the medical device MFG quality system, ensuring its continued compliance with relevant requirements.
- Attend design transfer meetings and be responsible for implementing and improving the medical device production quality system, ensuring its compliance with relevant requirements.
- Manage and review batch records and related documents in the medical device production process.
- Report on the operation of the medical device MFG quality system and drive the resolution of MFG NCs.
- Evaluate the compliance and effectiveness of the quality system during the medical device MFG process, participate in internal audits and management reviews, promptly provide feedback and quality improvement suggestions.
- Assist in the promotion and training of medical device manufacture related regulations and product standards.
Quyền lợi có gì?
Lương thưởng
Performance Bonus
Bảo hiểm & sức khoẻ
Health Care plan for you and your family
Học hỏi & phát triển
Learning and Development
