- Chức vụ: Thực tập sinh
- Kinh nghiệm: Không yêu cầu
- Hình thức làm việc: Toàn thời gian cố định
- Yêu cầu bằng cấp: Không yêu cầu
- Yêu cầu giới tính: Không yêu cầu
- Số lượng cần tuyển: 0 ứng viên
- Ngành nghề:
Y tế - Dược
Mô tả công việc
1. Manage Quality Assurance, Quality Systems, Quality Control, Regulatory Affairs,
Supplier Quality, Calibration, Complaint Handling, and Document Control staff.
2. Train company employees on compliance with Quality System standards 21 CFR
820, ISO 13485 and ISO 14971.
3. Develop and implement Quality System management strategies which integrate
with company annual and long term strategies.
4. Ensure company is regulatory inspection ready at all times (FDA, international
regulatory bodies and customers)
5. Direct investigations and implement corrective actions to resolve complaints and
6. Plan, coordinate and direct regulatory strategies for new products.
7. Participate with the Management Team in developing and implementing relevant
business and strategic plans.
Yêu cầu công việc
1. BS/MS in Life Science or Engineering
2. Minimum 3 years of experience at the Senior Manager, Associate Director or Director level
3. Certain years of experience in Quality Systems/Regulatory Compliance submissions of Class I and Class II medical devices is a plus
4. Extensive knowledge of CFDA Medical Device Regulation, ISO 13485, ISO 14971,
FDA QSR and CE marking
5. Proven track record of building successful teams.
6. Competence and confidence leading teams and developing a cohesive team
7. Proficient in Excel, Word, and MS Office/PC applications.
8. Excellent verbal and written communication skills in English Language.
Quyền lợi được hưởng
- 13th Bonus
- Training sessions