职位详情
SQE(外包 外资知名医疗器械)
1.2-1.6万
科锐尔人力资源服务(苏州)有限公司
苏州
5-10年
本科
01-05
工作地址

强生医疗器材公司长阳街299

职位描述



§ Conduct on-site quality and process
assessments at suppliers对供应商进行现场质量和过程评估。


§ Collaborate with the Manufacturing and
Quality engineers worldwide, in assessing and addressing supplier quality issues与全球的制造和质量工程师合作,评估和解决供应商质量问题。


§ Ensure effective and timely closure on all
Supplier Corrective Action Requests. 确保所有供应商纠正措施及时有效的关闭。


§ Ensure suppliers continue to meet J
Quality requirements with regard to Supplier Change Request process 确保供应商持续满足关于供应商变更管理的质量要求。


§ Generate quality metrics on supplier
performance and establish measures to monitor quality costs and avoidances建立供应商绩效的质量指标及监控质量成本和质量风险。


§ Facilitate the completion of the quarterly
Suppler Management Committee meeting完成季度的供应商管理委员会会议。


§ Provide project management leadership and
can manage multiple projects at given time提供项目管理领导力,并能在给定的时间内管理多个项目。


§ Provides guidance to Purchasing, Engineers
and stakeholders in applying supplier quality system requirements. 为采购、工程和利益相关者提供供应商质量体系要求的指导。


§ Participates in designing, developing and
executing design and manufacturing process validations/verifications and
determines appropriate sampling plans or proactive initiatives for subsequent
routine production. 参与设计、开发和执行设计及制造工艺的确认/验证,确定适当的抽样计划或为后续的日常生产提供积极的方案。


§ Engage with external customers/contacts
include outside technical contractors, suppliers, consultants, second and third
part auditors, and researchers. Internal
customers may include any or all of the following, New Product Development,
Research, Operations, Marketing, Legal, Sales, Clinical, Human Resources,
Quality and Regulatory departments与外部客户/联系人包括外部技术承包商、供应商、顾问、第二和第三方审核员和研究人员。内部客户可以包括以下任何一个或全部:新产品开发、研发、运营、市场营销、法律、销售、临床、人力资源、质量和管理部门。


§ Strong understanding of industry practices,
government reporting and legal matters, and strategic quality initiatives. 对行业惯例、政府报告和法律事务以及战略性质量方案有很强的理解力。


§ Develops solutions to problems of significant
scope and complexity to which might cause delays to program schedules and may
result in negative financial implications. 提供重大范围和复杂性问题的解决方案,这类问题可能会导致项目进度的延迟,并可能导致负面的财务影响。


§ Lead full responsibility for a product
launch and/ or transfers at one of the strategic suppliers领导战略供应商产品的发布和/或转移。


§ Participates in pre-production activities
for new and transferred products. 参与新产品和转移产品的前期活动。


§ Develop and implement efficient and
effective inspection points and control plans at the supplier site. 在供应商现场开发和实施有效的检查点和控制计划。



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