Source Quality Engineer

Auris Health

Auris Health

Quality Assurance
Suzhou, Jiangsu, China
Posted on Tuesday, September 12, 2023


§ 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&J Quality requirements with regard to Supplier Change Request process 确保供应商持续满足强生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

§ The above statements are intended to describe the general nature and level of work being performed by people assigned to this job/classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. 上述语句旨在描述分配给这项工作/类别的人员的一般性质和工作水平。它们不被解释为所有被归类的人员所需的所有职责、职责和技能的详尽清单


§ Manufacturing experience in machining or mechanical assembly product. 机加工或者机械组装品制造行业经验;

§ Experience in a ISO regulated environment; 在医疗行业法规性质的环境里工作的经验;

§ A minimum of 3 years of experience working in quality engineer; 3年以上QE经验;

§ Strong code of ethics强有力的道德准则

§ Ability to apply basic Quality tools/systems/processes to meet department goals and objectives. 能够运用基础的质量工具/系统/流程来达到部门的目标

§ Works independently on routine tasks; may require supervision to resolve more complex issues. 独立完成日常工作;可能需要监督以解决更复杂的问题