Các Phúc Lợi Dành Cho Bạn
Mô Tả Công Việc
1. Work as project manager and perform validations related to sterility assurance of sterile
medical devices from vendors in Asia, including but not limited to
a. ETO sterilization validation
b. Steam sterilization validation
c. Packaging validation
2. Supervise and train vendors for ISO standards and Medline requirements
3. Perform audits and vigilance audits for sterile products related quality system and process; follow up CAPA/ SCAR and ensure appropriate evidences in a timely manner
4. Perform root cause investigation, troubleshooting and problems solving when non‐ expected situation happens.
5. Perform new products adoption into validated sterilization cycle including but not limited
to bioburden, residual evaluation, packaging evaluation, etc.
6. Manage conflicts, interact with vendors and stakeholders, and communicate with internal team and cross‐functional teams.
7. Intensive travels to vendors to ensure meeting quality requirements.
8. Other work assigned by supervisor.
Yêu Cầu Công Việc
1. Bachelor’s degree or above with science or engineering background. Biological and chemical
background is preferred.
Relevant Work Experience
1. 1‐2 years’ work experience in manufacturing. Experience in medical device is an advantage.
2. Fluent at both verbal and written English.
3. Microsoft Word and Excel experience at an intermediate level
4. Willing to travel with rate 50%
5. Good teamwork spirit, Good problem solving skills
6. Familiar with requirements and standards related to ISO11135, ISO11607 is preferred
7. Project management skill is a plus