杭州招聘

Job Summary

Provides overall quality assurance leadership in the management and qualification of suppliers and/or external manufacturers (EMs).  Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives.  This position aids in the identification and eliminate supply chain risks via internal and supplier partnerships.  Leads/participates in supplier/EM engagements to assess technical competency and general compliance to requirements, i.e., material specifications, CTQ’s, process control plans, quality agreements, etc.  Key areas of focus within supplier management are performance monitoring/reporting, compliance to J&J standards and streamline processes.  Key areas of support provided to team members include; risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support.

 

Duties & Responsibilities

• Performs quality processes including; change control, supplier non-conformance, quality agreements.  Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives.  Lead supplier/EM quality evaluations.  Provide third party inspection support.   
• Lead defect resolution, root cause investigation, and continuous improvement activities.  Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.
• Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.  Provide Quality Engineering support to suppliers/EMs including verification/validation activities.  Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
• Accountable, as applicable   for compliance in accordance with Medical device and Drug regulations locally and countries where the products are marketed.
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessments.  Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas:  EM and Supplier Quality procedures, medical devices, and combination products.
• Provide guidance and develop of junior level SQE.

 

Experience and Knowledge Required

• ？Education: BA or BS degree
• ？Minimum of 7 years of experience as a professional in a regulated industry, preferred Medical Device
• ？Demonstrates a basic understanding of the Medical Device Quality Systems, emphases on purchasing controls.
• ？Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending.
• ？Up to 30% travel, Full Time with weekday business hours.

 

Experience and Knowledge Preferred

• Experience in the Medical Device industry
• ？Experience in the Pharmaceutical industry or Chemical, Packaging, or Plastics industry is an asset.
• FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Anvisa Australian TGA
  

眼力健(杭州)制药有限公司，坐落于下沙杭州经济技术开发区于1995年开始建造，1998年投产运营。是眼力健独家投资三千多万美元建造的生产护眼系列产品的工厂。

目前工厂已经获得了ISO全球23个国家和地区的准入批准，其中包括美国的FDA和加拿大的Health Canada以及中国的GMP。公司拥有行业领先的设备，按照无菌医药产品的标准生产。目前年产量约为5500万瓶。其中齐能品牌系列产品作为总公司隐形眼镜护理液的主打产品，以其特有的品质倍受中高收入群体的青睐。公司大部分产品出口到日本、美国、欧洲及亚太其他国家和地区。

满足不同年龄层客户的需求，是眼力健全体员工的奋斗目标。

我们的产品：隐形眼镜护理液包括全能系列智护系列，双氧水产品和Purite盐溶液，以及滴眼剂。销往国家和地区：产品销往日本、加拿大、美国、中国香港、新加坡、马来西亚、印度尼西亚、韩国、澳大利亚、新西兰、中国等。