sterilization灭菌经理/主管
麦朗(上海)医疗器材贸易有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:医疗/护理/卫生
职位信息
- 发布日期:2020-12-09
- 工作地点:武汉-江汉区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:1-2万/月
- 职位类别:质量管理/测试经理(QA/QC经理) 质量管理/测试主管(QA/QC主管)
职位描述
Job Description:
Supervise 5 direct reports to maintain current routine activity including but not limited to routine sterilization release and related data analysis, all sterilization/packaging related data analysis and database maintenance such as bioburden, EO/ECH residual , new product adoption, validations, etc.
Oversea Asia sterilizers’ performance by managing routine release and vigilance
Distribute routine release workload to direct reports, manage their performance by monitoring the release efficiency and accuracy on a quarterly basis. Seek opportunities for improvement.
Arrange unannounced vigilance, collect Medline vigilance report, compare data with vendor self audit report on a quarterly basis. Seek opportunities for vendor performance improvement.
Issue vendor performance report on a quarterly basis
Assist business department to adopt new product to an existing sterilization cycle, or qualify new cycles by doing below, or supervisor direct reports to do it, following appropriate timeline.
Perform on site and desk audit
ETO sterilization validation
Steam sterilization validation
Irradiation validation
Packaging validation
Review vendors’ own validation if vendor has ability to do it by their own
Train new hire/current team members, cross train other team members.
Ensure validation dataloggers and other equipments are calibrated within timeline.
Provide technical supports / suggestions to cross functional teams.
Seek cross function opportunities with other teams for a better supplier management process.
Requirement:
Bachelor’s degree with science or engineering background. Biological and chemical background is preferred.
Minimum 2 years working experience in related area and minimum 1 year management experience.
Fluent in English writing and reading.
Be familiar with ISO11135, ISO11137 and QSR820.
Be able to travel within China and overseas, travel frequency is about 30-50%.
公司介绍
Our Website: https://medlineasia.com.cn/
联系方式
- Email:hrchina@medline.com
- 公司地址:建设大道588号卓尔国际中心