高级质量工程师
常州巴奥米特医疗器械有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械 机械/设备/重工
职位信息
- 发布日期:2013-07-12
- 工作地点:常州
- 招聘人数:1
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
主要岗位职责Key Position Responsibilities
§ 直接向高级QA/QE主管汇报(虚线转移项目负责人汇报)。
Reports directly to Senior QA/QE supervisor (dotted line to transfer project leader).
§ 执行项目转移计划。
Implement project transfer plan.
§ 完成FAI
Complete First Article.
§ 创建检验标准。建立产品外观标准。
Create inspection criteria. Develop and improve visual /cosmetic standards.
§ 获得必需的量具,负责量具设计,量具图纸。
Procurement/obtainment of all necessary gages, gage design, gage prints.
§ 满足标准质量控制要求和完成过程能力分析。
Implement any SQC requirements and process capability analysis.
§ 每日MRB,每周质量趋势评审,跟踪NCR,验证和关闭NCR。
Daily MRB review, Weekly trend review with team, Follow up NCR(s), NCR(s) verification and closure.
§ 准备月度质量趋势报告。
Prepare monthly quality trend report.
§ 处理发送方拒收、SCAR、客户报怨(PER)。发送方质量相关的联系窗口。
Sending site rejections/SCAR/Customer complaints (PER) handling. As contact window of quality related for send site.
§ 培训操作工和检验员产品标准。
Train operators and QC inspectors on product acceptance criteria.
§ 使用超出规范量具的产品调查。
Investigate out of specification gage for the evaluation about the effect on the manufactured product.
§ 持续质量改进,防止生产和发运不合格产品给客户。
Drive continuous quality improvement, prevent the production and shipment of any defective products to customer.
§ 执行QMS程序。
Follow-up QMS procedure.
§ 除履行上述质量工程师的职责外,还需:
Except fulfill above responsibilities of quality engineer, also include:
- 作为小组成员的师傅,了解并熟悉更多的知识并能为团队成员(QE/助理QE/质量技术员)提供专业知识方面的指导。
As master or leader of team group, providing more guidance to team (QE/Assistant QE/Quality technician) regarding technical expertise and product specific knowledge.
- 质量体系的系统性改善,制定或更新QA有关的质量程序文件,标准化质量体系。
Systematic improvement on quality system, develop or update QA related procedure standardize the practice of quality system.
- 参加质量体系审核和月度现场巡视审核,识别质量体系进行机会。
Participate quality system audit and monthly shop floor walkthrough, identify the improvement chance for quality system.
- 积极参与持续改进,领导GB项目。
Lead GB project for continuous quality improvement.
经验Experience
技能和资质(使得目前可以去执行一些工作)Skills and Abilities (Can Do Criteria):
§ 两年以上医疗器械行业工作经验或精密加工或相等行业5年以上QA经验。
2 years experience in medical device company or 5 years QA experience in precision machining company or equivalent.
§ 有工程或相关专业背景。
Minimum of degree or equivalent in engineering or relevant technical discipline.
§ 良好的书面和口头英语。
Good written/verbal English communication skills
§ 良好人际沟通技能。
Good interpersonal and communication skills
§ 有同时独立完成多重任务的能力。
§ Independently capable of managing tasks for multiple project plans simultaneously
§ 独立处理问题的能力。
Independently capable of performing logical problem solving
§ 熟悉质量管理体系,了解TS16949 或 ISO13485。
Be familiar with quality management system, know about TS16949 or ISO13485
§ 熟悉各种测量工具和方法。
Be familiar with different measurement instruments and inspection methods.
§ 熟练运用质量统计技术(SPC, FMEA, MSA etc),质量分析工具进行质量改进。
Be professional on quality improvement tools (SPC, FMEA, MSA etc), practice statistical analysis technical, quality tools for quality improvement skillfully.
公司介绍
ChangZhou Biomet Medical Devices Co., Ltd. was wholly invested by the United States Biomet Group at the end of 2007, located in the EPZ XinBei region, Changzhou City. It mainly produces the third category of implantable medical device products. The total investment of ChangZhou Biomet is about 17.8 million U.S. dollars. Now we have CNC mill, DMG, CITIZEN and many other advanced precision machinery equipment. We provide positive and safe working environment, personal development, competitive pay and benefits and a variety of training opportunities. We sincerely invite you to join us to win the development of both company and individual.
美国BIOMET集团是一家闻名全球的医疗器械上市公司,创建于1977年,为全球三大骨科医疗器械生产厂商之一,在全球拥有19家工厂,50多个分支机构和6000多名员工。巴奥米特公司的产品已行销全世界100多个国家,2008年销售额 约25亿美金。自1994年巴奥米特公司的产品就一直被进口到中国,并在浙江金华和上海建有制造基地和销售中心。美国巴奥米特公司设计、制造的产品在世界上处于领先地位,其产品包括:重建和固定设备、电动骨骼生长刺激设备、支撑整形设备、手术设备、普通外科工具、关节复制产品、脊柱移植片、骨骼水泥剂、骨骼代替品、头盖上颌骨整形移植片、牙齿重建植片和相关的设备。
常州巴奥米特是由美国巴奥米特(BIOMET)集团于2007年底在中国独立投资的一家医疗器械有限公司,位于常州市新北出口加工区,主要生产植入人体的第三类医疗器械产品,,投资总额1780万美元。 常州巴奥米特公司现拥有加工中心,DMG,CITIZEN等多种先进精密机械仪器设备。公司提供良好的工作环境、个人发展空间、有竞争力的薪酬福利和各种培训机会,我们诚邀各位有志之士的加盟,赢取公司和个人共同的发展。
联系方式
- 公司地址:新北区出口加工区
- 邮政编码:213031
- 电话:(0519)85608050-8012