工作地点： 常州市	招聘人数： 1人	工作性质： 全职
工作经验： 5年以上	学历要求： 本科	年龄要求： 不限
性别要求： 不限	薪资待遇： 面议	更新日期： 2021-01-21

岗位职责：

工作综述Job Function:
Ensures Biomet products meet applicable requirements for sterility, cleanliness and biocompatibility. Be the in-house expert on all issues related to sterility, biocompatibility testing and critical systems testing and monitoring. Interface with regulatory agencies and auditors as required to ensure that the sterility program is fully compliant with QSR & ISO requirements.
确保Biomet的产品符合无菌、洁净度和生物相容性的相关要求。是有关无菌、生物相容性测试和关键系统测试和监测的所有问题的公司内部专家。是监管机构和审核员接口以确保无菌项目完全符合QSR和ISO的要求。
The overall responsibility of this position is to maintain and implement validation procedures. Dispose the quality issues for group (such as complaints from sending sites, internal critical MRB issues, daily MRB review, etc.)
全面负责工厂内的确认程序和实施，负责小组内各种质量问题的处理（外部发送方投诉处理、内部重大MRB处理、每日MRB评审等）。
工作职责Job Description
Assign work and evaluate performance for group members
对小组成员工作安排和成绩评估
Work with QC to complete the inspection during project transfer
协调QC资源完成项目转移中的检验
Establish and maintenance quality control plan.
创建和维护质量控制计划。
Any SQC requirements and process capability analysis.
满足标准质量控制要求和完成过程能力分析。
CAPA follow-up.
CAPA跟踪。
As leader of daily MRB, deal with Internal/external NCR and SCAR from send site.
主持每日MRB，处理内部、外部NCR和SCAR.
Follow up and define containment.
跟踪和制定围堵措施。
QMS procedure follow-up.
执行QMS程序。
Train technicians in proper microbial and particulate sampling techniques, and monitor the sampling program to assure accurate results.
对技术员进行适当的微生物和微粒抽样技术培训，并对抽样项目进行监测以确保取得正确的结果。
Train and provide technical support to technicians performing required tests on the RO/DI water system, compressed air system and other critical systems as required.
对技术员进行培训并提供技术支持以进行RO/DI水系统、压缩空气系统和其他关键系统要求的测试。
Maintain tracking/trending reports on microbiology/sterility related issues for management review.
维护微生物/无菌相关问题的跟踪/趋势报告以供管理评审。
Provide technical support for clean room design and maintenance.
为洁净室的设计和维护提供技术支持。
Provide technical support for equipment and process validation.
为设备和工艺的确认提供技术支持。

职位要求：

Bachelor's degree (B. A.) in microbiology, from four-year college or university; and five years related experience and/or training; or equivalent combination of education and experience.
微生物学四年本科学历；五年相关工作经验和/或培训；或同等教育程度和经历。
Ability to utilize basic statistical methods for analyzing data.
能够运用基础的统计方法分析数据。
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
能够解决实际问题并在只存在有限变量时处理各种各样的确定变量
Microsoft Office, Minitab or equivalent.
微软办公系统，统计软件或同等软件。
Professional and ethical conduct
专业的道德操守
Committed to strive for excellence in the execution of required responsibilities
在执行要求的职责时能够致力于追求卓越
Committed to continuously improve English communication skills and cultural awareness
致力于不断提高英语沟通能力和文化意识
Committed to continuously learn as needed to perform the required responsibilities
致力于不断学习以执行所要求的职责
Learn the regulatory requirements for the Medical Device Industry
学习医疗器械行业的法规要求
Good interpersonal and communication skills
良好人际沟通技能。
备注：薪资为系统默认选择，请忽略。