常州招聘

SUMMARY OF POSITION: Responsible for leading the Supplier Quality Assurance function.
Work closely with Manufacturing, Materials, and Engineering teams in the assurance that all
suppliers are capable of providing materials and services that satisfy corporate requirements.
Provide focused quality engineering support primarily within the Purchasing Controls portion of
the Quality Systems. Be responsible for assignment of component quality requirements using
auditing and risk-based decision-making techniques, including assessing gauging techniques and
competency, writing quality plans, and coordinating technical requirements with appropriate
groups. Manage the supplied component portion of the non-conforming (NCR) process,
ensuring that appropriate root cause analysis and corrective actions are implemented and quality
data is trended and reported upon a routine basis. Supports the development of and enforces
internal systems and procedures to meet ISO standards and FDA quality system regulations.
ESSENTIAL FUNCTIONS:
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Practical implementation of Supplier / component systems and procedures for meeting
ISO standards and FDA quality system regulations.
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Review and perform routine and qualification audits at supplier locations in accordance
with FDA and ISO standards (as appropriate). Ensure that modifications are documented
and compliance is demonstrated through objective evidence.
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Create and verify that systems are in place to ensure appropriate control of incoming
product receipt and inspection according to FDA and ISO requirements.
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Assist with communicating customer print and GD&T requirements to the supplier and
develop necessary measures to guarantee documented compliance.
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Design inspection processes / requirements to be utilized by the suppliers at the point of
manufacture and ensure their integration into the supplier's manufacturing processes.
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Specify required inspection equipment and holding apparatus to accommodate repeatable
measurements.
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Work in conjunction with customer quality to ensure all customer requirements are
distributed, understood, and adhered to at the supplier level.
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Support Lean/Six Sigma initiatives to remove variability and reduce cost to improve
quality and reduce the cost of incoming components as requested.
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Provide on-site supplier support for special projects as requested.
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Lead the outsourcing initiative for all machined and raw components at the site level
including system development / improvement.
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Represent Paragon Medical in meeting with suppliers to fully communicate the
customers requirements or as required in the manufacture of contracted products.
OCCASIONAL DUTIES: Internal audits to applicable standards. Gage R&R studies both
internal and external. Collect data and develop SPC both internally and externally. Produce /
amend customer documentation when required. Completion of special projects when identified.
Once employee demonstrates competency in position, he/she may be required to train others in
similar roles.
amend customer documentation when required. Completion of special projects when identified.
Once employee demonstrates competency in position, he/she may be required to train others in
similar roles.
SKILLS: 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. Professional demeanor required.
PHYSICAL DEMANDS AND WORK ENVIRONMENT: The physical demands and work
environment characteristics described here are representative of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential
functions.
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Physical demands: While performing the duties of this job, the employee is required
throughout the workday to stand; walk; sit; use hands to handle objects; reach with hands
and arms; stoop; talk or hear. Specific vision abilities required by the job include close
vision and may also include color vision; depth perception; and the ability to see print in
various sizes and formats. May be required to climb stairs, kneel or crouch. May be
regularly required to pull and push up to 15 pounds and occasionally lift boxes up to 25
pounds.
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Work environment: Work performed in an office environment. The noise level in the
work environment is usually low. On occasion work environment will be dependant
upon sites being visited. Various levels of noise and mild chemical exposure may occur.

派瑞格集团位于世界外科医疗的“首都”-美国沃索，是首选的、可提供世界一流水平系统方案的“交钥匙”供应商。派瑞格集团自1991年成立以来，在美国、欧洲和亚洲创建了卓越的战略中心，工厂分布在美洲和亚洲，长期为世界顶尖的医疗器械生产商配套，同时也为中国国内顶尖的医疗器械生产商服务。设在美国的“全球设计中心”将服务从专业制造延伸到了客户的产品研发和样品试制，通过独特的质量管理体系，派瑞格承诺给世界范围的医疗器械行业的OEM商提供创新的、快速响应的系统方案。
派瑞格医疗器械（常州）有限公司创建于2007年5月，投资总额1850万美元，是美国派瑞格医疗国际公司在亚洲投资的全资美资公司，是派瑞格集团亚太区重要的出口生产基地。公司给全球一流的医疗器械公司专业生产符合不同国家法律法规要求的一类骨科医疗器械，器械盒和托盘，三类6846植入材料和人工器官的制造等，并可设计并销售自产产品。
我们的远景：成为全球外科手术市场上产品和成套器械管理方案的首选供应商。
我们的使命：通过设计和提供高精密的医疗器械产品，高效及时交付系统，试验和植入器件来服务于全球外科手术器械市场。
我们的质量方针：第一次就把事情做对。
更多企业信息，请关注我们的企业网站：http://www.paragonmedical.com