杭州招聘

职位描述：

Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality polices and procedures, and relevant regulatory requirements and industry guidance, including:

 - Document control and review/approval of controlled documents

 - Change management and review of change controls

 - Investigation and CAPA management, including robust root cause analysis

 - Complaint management and performance of complaint investigations

 - Supplier quality management and performance of supplier audits as appropriate

 - Internal audit program and performance of internal audits

 - Training program; conduct training when needed

 - Implementation of Quality Risk Management in relevant aspects of the QMS

 - Management Review

 - ISO certification and maintenance

 

Lead and/or support the oversight of product realization and commercial manufacturing  activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.

 

Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming  product.

 

Customer support, including:

 - Support customer audits, including response and corrective action tracking

 - Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.

Bachelor’s Degree – Life Sciences or Engineering.

 

Minimum five (5) years of experience in a regulated industry, such as life sciences, food and beverage, automotive or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device).

 

Minimum three (3) years in a Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment.

 

Strong knowledge of ISO and/or  cGMP requirements and relevant  industry standard practices is required.  Must have ability to interpret these regulations to ensure proper implementation in the plant systems.

 

ASQ certifications desirable (e.g. CQE, CQM, CQA)

 

Demonstrated understanding of Lean Manufacturing concepts desirable

 

Excellent analytical / problem solving, project management, interpersonal and organizational skills required.

 

Must have excellent verbal and written communications skills to interact with internal and external personnel on plant processes, projects, and investigations.

 

 Must work well in a team environment, possess an ability to adapt to change in the environment, and  have proven ability to exert influence in a directive and positive manner. 

 

Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project

 

举报 分享

金普奥膜科技（杭州）有限公司是由法国圣戈班集团（世界500强）全资收购的一家全资子公司。
研发与生产基地位于浙江省杭州市萧山高新技术开发区桥南区，占地面积15亩，厂房建筑面积15000㎡。其中已启用模具加工车间1000㎡，设备加工车间1000㎡，注塑加工车间1500㎡，洁净生产车间2500㎡。
公司设有市场营销、质量控制、研发设计、产品制造、采购、物流、办公及财务等部门。
公司立足于研发国际过滤市场需求的高端过滤产品，从设计、开发到批量生产等都具有独创性。公司将重点放在科技创新产品及自主知识产权的研发，现已拥有多项国内外发明专利，并于2011年荣获“***高新技术企业”称号。
公司产品广泛使用在制药、医疗、食品饮料及电子制造业等行业。95%销往欧美和亚洲发达国家，客户多为世界500强企业，如强生、罗氏、爱尔康、Hologic，3M、英特尔、TSMC、三星、LG等公司。
公司实施国际化企业管理模式，从质量到环境及职业健康均按照国际标准执行。公司已具有多项生产企业需具备的管理证书，如ISO-9001:2008、ISO13485:2003、ISO14001:2004及OHSMS18000等。
公司同时具备健全的福利及劳动管理制度，使员工遵守公司各方面的细节要求的同时，也明确自己的基本责任、义务及权利范围。
公司对企业用工采用人性化管理，重视人才培养的平台搭建，发挥员工自我奋发精神和集体协作精神，在企业稳定发展的同时，为集团培养多元化技术人才及高质量的生产员工做出贡献。