美国美联实业有限公司上海代表处

JOB RESPONSIBILITIES:
1.Responsible for assigned sterilization validation activities in China including writing sterilization protocols, organizing sterilization activities, coordinating projects with vendors, supervising and performing studies, shipping samples, basic analysis of data and preparing reports. Involves working with ethylene oxide, steam and gamma radiation sterilization processes.
2.Problem solving sterilization processes in China with input from Corporate Sterilization.
3.Communicating with sterilization suppliers and Medline vendors
4.Perform audits of sterilization facilities, medical device manufacturers and laboratories. This includes reviewing sterilization documentation and records.
5.Maintain copies of sterilization projects performed in China and the Far East for projects under their supervision.
6.Perform internal and external audits against sterilization procedures, US Food and Drug Administration Quality System Regulations and ISO international standards.
7.Works safely with steam, radiation and ethylene oxide sterilization processes.
8.Assures sterilization test equipment is within required calibration dates. Works with Corporate Sterilization to recalibrate instruments when required.
9.Works with sterilization validation equipment for measurement of temperature, moisture and radiation dose.
10.Supervises and trains plant personnel for performance of sterilization studies1
1.Reviews and maintains sterilization records for performance against specifications1
2.Approving sterilization facilities for use by Medline contract manufacturers1
3.Evaluate and audit microbiology laboratory facilities located in China. Train personnel when needed on aseptic microbiological techniques such as sterility testing, growth promotion studies, bacteriostasis and fungistasis testing, Dvalue and bacterial resistance testing, radiation quarterly dose audit testing, bioburden and environmental testing. Coordinate microbiology laboratory studies performed in China1
4.Translate sterilization related documents to and from Mandarin and English1
5.Coordinate sterilization agreements with vendors and other Medline personnel and representatives.1
6.Work with Medline purchase agent in China to review and approve new vendors for manufacture of sterile products or components to be pretreated and used in sterile products.EDUCATION:BS degree in Microbiology, Engineering or life science.Strong microbiology and laboratory coursework or experience is preferred.QUALIFICATIONS:Knowledge of AAMI and ISO sterilization standards and validation methods is desirable.Basic knowledge of laboratory procedures for bioburden/environmental monitoring, biological indicator testing and sterility testing.Computer literate. Microsoft Word and Excel experience at an intermediate level is required.Must be willing to work in environments where hazardous chemicals and substances may be encountered. Extensive travel required (70%). Weekend work required.This job description in no way states or implies that these are the only duties to be performed by the incumbent. He/she will be required to follow any other instructions and to perform any other duties as requested by his/her supervisor.

Medline was founded in 1966 but its roots date back 90 years when it started as a garment manufacturer. Since then, Medline has grown into Americas largest privately-held national manufacturer and distributor of health care supplies and services. Today, Medline manufactures and distributes more than 100,000 medical products, encompassing medical-surgical items and one of the largest textile lines in the industry. Please visit our website for more information.