Mô tả công việc
- Assist in establishing, implementing, and maintaining the Quality Management System to ensure compliance with relevant standards and regulations.
- Responsible for the assessment and review of supplier qualification, performance, and process capability. Cooperate with procurement and suppliers on quality improvement. Responsible for supplier issues handling, analysis, and improvement.
- Collaborate in new product transfer by defining and reviewing product quality standards and inspection protocols.
- Involve in product transfer and validation activities, and responsible for the quality documents are created and maintained up to date. E.g. process follow, risk management, quality control plan, DMR, create the inspection criteria.
- Monitor quality control processes during production to ensure products meet design and/or customer specifications.
- Responsible for non-conforming product handling, root cause investigation and corrective/preventative actions, together with effectiveness checking.
- Responsible for customer complaint handling, cooperating with relevant teams on root cause analysis, action plan, and customer response. Maintain good communication with customers on quality improvement.
- Authorize the release (COC) of products, COA review and approval.
- Monthly data analysis on product quality metrics and quality objective.
- Any other duties as assigned from time to time.
Yêu cầu
- Diploma or above.
- Can use English or Chinese
- Qualified ISO 13485:2016 internal auditor. Be familiar with ISO 14971:2019, Cleanroom, and related medical device standards and regulations.
- Effective communication and interpersonal skills to collaborate with multi-functional teams.
Thông tin khác
Loại công việc
Nhân viên toàn thời gian
Cấp bậc
Kỹ thuật viên / Kỹ sư
Học vấn
Cao đẳng
Kinh nghiệm
2 - 5 năm kinh nghiệm
Giới tính
Bất kỳ
Ngành nghề
Kỹ thuật ứng dụng / Cơ khí
,
Sản xuất / Vận hành sản xuất
,
Điện / Điện tử
Thông tin chung
- Thu nhập: 20 triệu - 30 triệu
Nơi làm việc
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Ứng tuyển bên dưới:
Hạn nộp: 11/05/2026