QA Specialist (Engineering Change Notice)

Lương không công khai

Hồ Chí Minh (On-site)

Nghỉ trọn T7, CN

Hạn chót 12/12/2026

Đăng 8 giờ trước

Ít hơn 5 ứng viên

Yêu cầu công việc

Qualification:

• Education level: Bachelor's degree at least

• Working experience: 3-5 years working experience, at least 3 years’ experience on quality control or supplier quality management

• Specific knowledge: Quality system knowledge of ISO13485 or IS09001 is a plus

• Language: excellent verbal and written English.

Core Competency (MSF):

• Good communication and coordination skills

• Detail-oriented

• Strong sense of urgency

• Strong self-learning willingness and ability

• Good skill in Office software.

Yêu cầu nên có

Knowledge of ISO 13485 or ISO 9001 quality systems

Công việc cụ thể là gì?

JOB SUMMARY:

This QA Specialist is responsible for meticulously reviewing Engineering Change Notice (ECN) requests by following the approval guideline to identify if the change details are in accordance with requirement, therefore to assure the product quality and regulatory compliance.

CORE JOB RESPONSIBILITIES:

1. ECN Request Review and Documentation

  • ECN change types including work/process instruction, BOM changes, component data changes and finished good data changes
  • Review all necessary documentation and the proposed change by following the ECN approval guideline
  • Verify critical information by using Medline internal quality management systems
  • Approve or reject the ECN within required period of time
  • Keep close relationship with initiator, divisional QA, sourcing team with effective communication to ensure request to move on smoothly
  • Maintain well on all the documentations of ECN requests.

2. Alignment and Enhancement of ECN Process

  • Report the ECN case progress with divisional QA and team members in regular basis
  • Constantly identify the areas can be improved on the ECN reviewing and approval process with feasible actions to implement

3. Other tasks assigned by manager or divisional QA.

• Ngày làm việc: T2 - T6 • Giờ làm việc: 09:00 - 18:00 • Cấp bậc: Có kinh nghiệm • Loại công việc: Toàn thời gian

Quyền lợi có gì?

Lương thưởng

13th Monthly Salary, Full paid for Social Insurance, Medical Insurance, Competitive salary and Bonus

Văn hoá công ty

Company/Team outing trip, Annual Party