Sterilization Engineer
本泽商贸(上海)有限公司
- 公司规模:少于50人
- 公司性质:外资(欧美)
- 公司行业:贸易/进出口
职位信息
- 发布日期:2017-11-17
- 工作地点:上海
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:16-26万/年
- 职位类别:质量管理/测试工程师(QA/QC工程师) 质量检验员/测试员
职位描述
职位描述:
Reports to: Technical Quality Manager
BASIC QUALIFICATION
? Minimum 3 years’ experience auditing in the EO sterilization at medical device industry
? Bachelor’s degree in a technical engineering field
? Medical Device Quality System Knowledge Including MDD93/42/EEC & ISO 13485, ISO11135:2014
REQUIRED COMPETENCIES
? Experience with CAPA, complaint investigation, risk management, EO sterilization knowledge
? Excellent written and verbal communication skills are essential.
? Strong computer skills
? Strong organizational and time management skills
? Ability to review, analyze, summarize, and draw conclusions and make appropriate recommendations and decisions; write reports;
? working with supplier to resolve sterilization quality issues
KEY RESPONSIBILITIES
? Process audit to the sterilization process
?Execute CAPA and non-conformance tracking to ensure corrective actions are addressed for all sterilization activities.
? Assist suppliers in developing and executing sterilization validations.
Provide NC and CAPA support for NCs involving sterilization issues as needed.
?writing and execution / coordination of sterilization protocol testing and the respective final report.
?Coordination of sterilization qualification and requalification activities with sterilization suppliers.
?Coordinate of testing of qualification and requalification activities (bio-burden, sterility, residual testing).
?Monitor, analyze and drive improvement in supplier performance, including audit findings and CAPA.
?Act as a liaison between 365 healthcare Shermond and its suppliers.
? All other duties as assigned.
? This job involves domestic travel, up to 20%
Reports to: Technical Quality Manager
BASIC QUALIFICATION
? Minimum 3 years’ experience auditing in the EO sterilization at medical device industry
? Bachelor’s degree in a technical engineering field
? Medical Device Quality System Knowledge Including MDD93/42/EEC & ISO 13485, ISO11135:2014
REQUIRED COMPETENCIES
? Experience with CAPA, complaint investigation, risk management, EO sterilization knowledge
? Excellent written and verbal communication skills are essential.
? Strong computer skills
? Strong organizational and time management skills
? Ability to review, analyze, summarize, and draw conclusions and make appropriate recommendations and decisions; write reports;
? working with supplier to resolve sterilization quality issues
KEY RESPONSIBILITIES
? Process audit to the sterilization process
?Execute CAPA and non-conformance tracking to ensure corrective actions are addressed for all sterilization activities.
? Assist suppliers in developing and executing sterilization validations.
Provide NC and CAPA support for NCs involving sterilization issues as needed.
?writing and execution / coordination of sterilization protocol testing and the respective final report.
?Coordination of sterilization qualification and requalification activities with sterilization suppliers.
?Coordinate of testing of qualification and requalification activities (bio-burden, sterility, residual testing).
?Monitor, analyze and drive improvement in supplier performance, including audit findings and CAPA.
?Act as a liaison between 365 healthcare Shermond and its suppliers.
? All other duties as assigned.
? This job involves domestic travel, up to 20%
职能类别: 质量管理/测试工程师(QA/QC工程师) 质量检验员/测试员
关键字: 医疗用品 灭菌 供应链 质量控制 质量管理
公司介绍
Bunzl PLC is a fast-growing global company specialized in the outsourcing of supply chain management. We are head quartered in London with Operating Companies in more than 32 countries, including North America, South America, Europe, UK & Ireland, Australia and New Zealand, Asia. We are listed on FTSE with annual sales of £10 Billion (US$14 Billion).
Bunzl Trading (Shanghai) limited is a subsidiary of Bunzl plc. We are incorporated in Pudong Shanghai, China and its main responsibility is to furnish sourcing service in Asian areas for Global Bunzl Companies, not limited to China, Vietnam, Malaysia, Thailand and
The position here will offer the successful candidate a fantastic career development opportunity both on a local and international basis. You will have the opportunity to join Bunzl China on the ground floor and will be working for a highly successful global company with a team of great people.
BUNZL PLC是一家全球性跨国公司,主营供应链式采购营销业务。总公司位于英国伦敦,为FTSE上市公司,年营销额100亿英镑(140亿美金),分公司遍及北美,南美,欧洲,英国和爱尔兰,澳洲及新西兰, 亚洲等32个国家。BUNZL SHANGHAI(本泽商贸上海有限公司)为BUNZL PLC在中国上海浦东设立的分公司;
Bunzl Trading (Shanghai) limited is a subsidiary of Bunzl plc. We are incorporated in Pudong Shanghai, China and its main responsibility is to furnish sourcing service in Asian areas for Global Bunzl Companies, not limited to China, Vietnam, Malaysia, Thailand and
The position here will offer the successful candidate a fantastic career development opportunity both on a local and international basis. You will have the opportunity to join Bunzl China on the ground floor and will be working for a highly successful global company with a team of great people.
BUNZL PLC是一家全球性跨国公司,主营供应链式采购营销业务。总公司位于英国伦敦,为FTSE上市公司,年营销额100亿英镑(140亿美金),分公司遍及北美,南美,欧洲,英国和爱尔兰,澳洲及新西兰, 亚洲等32个国家。BUNZL SHANGHAI(本泽商贸上海有限公司)为BUNZL PLC在中国上海浦东设立的分公司;
联系方式
- 公司地址:中洲控股中心A座7楼