职位详情
供应商质量工程师(外资知名医疗器械)
1.5-2万
科锐尔人力资源服务(苏州)有限公司
苏州
10年以上
本科
09-02
工作地址

强生医疗器材公司江苏省苏州市吴中区长阳街299号

职位描述

· Support
supplier transfer projects and serve as primary liaison for all actions
associated with new supplier requirements


· Transfer
of components and raw materials to new suppliers


· Continuously
monitor risk of the existing suppliers /components and define risk mitigation
plans


· Support
the transfer of product improvements into production utilizing Design for
Manufacturing (DFM) principles.


· Lead
analysis of defective components in Incoming Inspection and work with vendors
to resolve


· Manage
supplier process validation activities by applying a risk based approach


· Implement
continuous improvement within supply chain


· Lead/support
the supplier evaluation process when selecting & qualifying new suppliers; help
maintain the ASL, supplier scorecards, and supporting documentation required
per SOPs


· Resolve
incoming inspection yield issues by driving tighter vendor process capabilities
and ensuring appropriate internal drawing tolerances


· Ensure
compliance of manufacturing processes and areas to all applicable quality
system regulations


· Monitor
and analyze production information to support risk management and to provide
direction for corrective and preventive actions and/or process improvement
activities (CAPA)


· Validate
manufacturing and supplier processes, including activities associated with
equipment installation qualification (IQ), operational qualification (OQ), and
performance qualification (PQ)


· Work
with manufacturing engineering and supply chain to ensure necessary process
controls and validations are in place and best practices are followed (GMP)


· Identify
key process input variables and key process output variables.


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