无锡招聘

职位描述：
职位目的：为一个快速发展的医疗器械材料和部件制造公司提供强健的质量保证支持，确保在扩能过程中的产品质量；工作内容包括领导和管理工艺风险管理和工艺验证过程，进行数据分析以推动达到***工艺和生产能力；通过监管和培训使各项操作均能达到GMP标准等等。
 
工作责任:
1、 为公司提供有效的质量保证服务。
2、以数据为导向的责任. 运用加工能力工具和技术以达到数据统计评估及公司生产质量改善的目标和结果。
3、积极维护世界级的质量和生产率。
4、对公司生产工艺和质量保证方面的新员工给予培训和指导.
5、建立并维护公司的质量管理系统并确保其持续改进和通过ISO认证。熟悉ISO13485。
6、寻找并运用工业***模式来确保公司生产的产品具有***品质.
7、与生产部及技术合作伙伴建立并保持紧密联系。
8、协助总经理, 并与其它高层管理人员密切合作以达到公司的目标。组织管理评审和内审。
9、本岗位描述可由公司随时修改.
 
综合素质:
1、对责任范围内的所有工作均追求卓越, 并注质量保证, 现金产出和资本产出率。
2、具有较强的创造性、想象力、沟通能力及协调能力。
3、敢于对所有结果负责。
4、对学习抱有热情。
5、对工作持有积极向上、肯定的心态。
6、尊重我们的员工、客户、技术伙伴及投资者。
 
绩效评估方法:
1、质量保证. 评估: 通过具体的质量指标以达到公司质量目标，维护并不断改善公司的ISO质量管理体系，培训相关人员
2、工作态度, 主动性和自我激励性. 评估：员工、客户、技术合作伙伴及投资方通过公司年度调查记录进行评估反馈。
3、工作禁忌: 缺乏主动性, 不诚实, 缺乏创造性, 工作效率低下.
 
工作要求:
1、工作经验 ：3-5年相关工作经验
2、专业背景要求: 有很强的工艺工程方面的专业背景. 熟悉医疗器械制造过程(包括洁净室认证)者优先考虑.
3、学历要求：本科及以上学历
4、年龄要求：No limit. 不限
5、：双语：英语/汉语（质量背景很强的人员，可适当降低英语方面的要求）
    简历投递需中英文
6、工作地点: 江苏江阴

English
Purpose of Position: Give strong quality assurance to medical material and component manufacturing to maintain stable quality in a fast growing environment; work content includes leading and managing process risk management and process validation, data analysis to promote for best process and manufacturing capability; giving supervision and training to achieve Good Manufacturing Practice; etc.
 
Work Responsibilities:
1. Proactive quality assurance services for the company
2. Data-driven responsibility. Applies and interprets process capability tools and techniques for purposes of statistical evaluation and improvement of the company’s quality control processes and results.
3. Passionate maintenance of world-class quality and productivity
4. Trains and calibrates new employees in the company’s manufacturing processes and quality assurance procedures
5. Owns and maintains the company’s quality management system and ensures its continuous improvement and sustained ISO certification. Familiarity with ISO 13485 is a plus.
6. Seeks out and applies industry best-practices for assuring the highest possible quality for the company’s products
7. Develops and maintains a close working relationship with the manufacturing department and our technology partners’
8. Provides assistance to the General Manager and works closely with the senior management team in order to achieve the company’s goals. Conducts Management Reviews and performs internal audits
9. This job and its duties can change at any time at the discretion or the company.
 
 
General Requirements:
 
1. Must have a passion for excellence in all areas of responsibility with special focus on quality assurance, cash-generation, and financial productivity
2. Must possess strong creativity, imagination, communication and coordination skills
3. Must be responsible and accountable for results
4. Must have a passion for continuous learning
5. Must have a positive, can-do attitude about work
6. Must treat our employees, customers, technology partners and owners with dignity and respect
 
Performance Evaluation Criteria:
1. Quality assurance leadership for the company. Measure: Achievement of company’s quality goals reflected in specific quality metrics. Maintenance and continuous improvement of the company’s ISO-certified quality management system. Trained, competent staff.
2. Work attitude, initiative, and self-motivation. Measure: Assessment of feedback from employees, customers, technology partners, and owners of the company via annual documented survey.
3. Unacceptable behavior: The Company will not tolerate lack of initiative, lack of integrity, lack of creativity or low work efficiency in the performance of any of these duties.
 
Job Requirements:
1. Work Experience:
         3- 5 years relevant experience
2. Specialist Skills:
         Strong background in quality assurance. Prefer familiarity with medical device manufacturing processes, including Clean Environmental Room protocols.
3. Education Level:
         Bachelors degree or above
4. Age Requirement:
         No limit
5. Other:
         Bi-Lingual: English / Chinese (Quality background is very strong, can properly reduce the requirement of English)
6. Location:
         Jiangyin, Jiangsu Province
 
工作地址
江苏江阴国家高新区东盛西路6号D4座 举报 分享

江阴法尔胜佩尔新材料科技有限公司(Jiangyin Fasten-PLT Materials Science Company Ltd. （Peier）)是中美合资企业，2003年3月由上市公司江苏法尔胜股份有限公司(Fasten)和美国太平洋资源国际有限公司(Pacific Resources International Co., LLC (PRI))和美国LDT公司(Lumenous Device Technologies Co., LLC (LDT))共同投资（其中法尔胜占50%股份）建立。公司注册地址为江苏省江阴市滨江开发区东区。
    公司生产和销售生物医用、民用和工业用镍钛合金丝材及其深加工产品(诸如温控弹簧、热-机械驱动装置、通讯天线和终端用户天线)、合金窄带和特殊材料产品；客户委托激光微加工冠状动脉支架、血栓滤器、外周边血管支架、自膨胀腔道支架和超薄支架等。公司接受国外委托加工和组装医疗器械用原材料部件和组件，拥有符合要求的洁净车间和组装设备。公司还受国外公司的委托开展激光微加工系统的安装和调试、激光微加工医疗器械的技术培训和指导。
    公司十分重视政策法规投入，2005年1月公司通过了英国标准协会(BSI)的ISO13485：2003认证：“为医疗器械制造商进行激光微加工和电解抛光；生产和销售医用Ni-Ti合金丝材”，在生物医学材料产业和形状记忆与超弹性合金产业领域成为国内外客户认可的企业。
    自创建以来，公司重视高新技术产品的研发，并形成了一支精干的研发队伍，现拥有博士3名，高级工程师5名，60%的员工具有大专以上学历。先后承担国家及省部级新产品开发项目16项，获一项国家科技进步二等奖，拥有国家专利14项。
    公司愿与国内外有识之士精诚合作，共同发展，积极推动生物医学材料产业的快速发展。