常州招聘

SUMMARY OF POSITION: Responsible for meeting customer requirements for the manufacturing of surgical instruments from receiving raw material through to the shipping of finished goods. Supports the development of and enforces internal systems and procedures to meet ISO standards, SFDA, and FDA quality system regulations. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use

职位概要：负责从接收检验到成品发货的整个过程中满足客户在外科器械制造方面的要求。支持并加强内部体系和程序的开发以满足ISO标准、SFDA和 FDA法规质量体系。开发并实施必要的检验/确认技术从而在生产过程的最早期验证产品是否满足要求。指定和实施新的检验设备并指导其他人员恰当的使用这些设备。

ESSENTIAL FUNCTIONS:

基本职能

§ Practical implementation of systems and procedures for meeting ISO standards,SFDA and FDA quality system regulations.

参与实施体系和程序以满足ISO标准、SFDA和 FDA法规质量体系。

§ Supervise and train personnel in the inspection of raw materials, in-process and finished goods using statistical sampling techniques and precision measuring instruments to check conformance to requirements.

监督并培训原料接受检验、过程检验和成品检验，使用抽样统计技术和精密的测量设备来检查对要求的符合性。

§ Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per SFDA,FDA and customer requirements.

验证员工已经遵守了所有的生产程序，并且已经按照SFDA、FDA和客户的要求对器械主记录和器械历史记录等记录进行了维护。

§ Design inspection/validation steps to be taken by the machinist at the point of manufacture and integrate these steps into the manufacturing instructions.

设计在生产时机械师所要采取的检验/确认步骤，并将这些步骤整合到生产指导中。

§ Specify required inspection equipment and holding apparatus to accommodate repeatable measurements.

指定所要求的检验设备和夹持夹具，以此来提供可重复的测量。

§ Work in conjunction with Business Unit Leaders and Cell Leaders to ensure machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc.

和生产车间主管及班组长一起工作，确保机械师具有使用和管理维护敏感测试设备以及相关要求（比如校准、数据记录、预期变差等）的知识，并有能力进行这些活动。

§ Assist/lead company Lean/6 Sigma initiatives to remove variability and reduce cost. Q.E. is responsible for ensuring cell processes are correctly base-lined and controlled. Known variability is to be accounted for through selection and frequency of inspection or sampling plans.

协助/领导公司的 lean/6 sigma 来消除变差并降低成本。QE负责确保车间过程正确的受控，并在选择、制定检验频率或抽样计划的全过程中考虑已知的变差。

§ Provide recurring support to assigned inspection technicians.

在任命检验技术员方面提供支持。

§ Assist in the inspection of surgical instruments and implants as required. Lead or assist in leading multi-function continuous improvement activities.

要求时，协助外科器械和植入器械方面的检验工作。领导或协助多功能持续改进活动。

§ Represent Paragon Medical (Changzhou) in meeting with Customers to fully develop their requirements or as required in the manufacture of contracted products. Assist in both internal and external audits of all corporate quality systems and demonstrate compliance through objective evidence.

代表派瑞格医疗（常州）与客户开会，以此来充分地开发客户的要求，或在要求时参与合同产品的制造。协助进行公司的内部和外部审核，并通过客观证据证明其符合性。

§ Be responsible for development of Control Plan and other duties assigned for NPI

负责开发控制计划和其他 NPI过程中要求的任务。

§ Participate in handling customer feedback and return

参与客户反馈和客户退货的处理。

§ Handle the out of control and IDR in work cell

处理车间里的失控问题和IDR。

OCCASIONAL DUTIES: Gage R&R studies, training others in statistical techniques and process control/validations. Calibrate and control all gages and measuring equipment used in production.

临时任务：Gage R&R 研究，在统计技术和过程控制/确认方面培训其他人员。校准和控制生产中使用的量具和测量设备。

EXPERIENCE AND EDUCATION:

经验和教育：

l 4 year degree in Quality Engineering or related field. Willing to consider relevant experience in combination with professional certifications.

在质量工程或相关领域有4年学历，如果有专业证书，愿意考虑相关的经验。

SKILLS:

技能

Excellent interpersonal, problem solving and communication skills. Individual is able to work with minimal supervision and actively participate in a team oriented, continuous improvement, manufacturing environment.

优秀的人际关系、问题解决和沟通技巧。个人能在最少的监管下工作并能积极地参与团队导向的持续改进和制造环境。