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§ Conduct on-site quality and process
assessments at suppliers對(duì)供應(yīng)商進(jìn)行現(xiàn)場(chǎng)質(zhì)量和過程評(píng)估。


§ Collaborate with the Manufacturing and
Quality engineers worldwide, in assessing and addressing supplier quality issues與全球的制造和質(zhì)量工程師合作，評(píng)估和解決供應(yīng)商質(zhì)量問題。


§ Ensure effective and timely closure on all
Supplier Corrective Action Requests. 確保所有供應(yīng)商糾正措施及時(shí)有效的關(guān)閉。


§ Ensure suppliers continue to meet J
Quality requirements with regard to Supplier Change Request process 確保供應(yīng)商持續(xù)滿足關(guān)于供應(yīng)商變更管理的質(zhì)量要求。


§ Generate quality metrics on supplier
performance and establish measures to monitor quality costs and avoidances建立供應(yīng)商績(jī)效的質(zhì)量指標(biāo)及監(jiān)控質(zhì)量成本和質(zhì)量風(fēng)險(xiǎn)。


§ Facilitate the completion of the quarterly
Suppler Management Committee meeting完成季度的供應(yīng)商管理委員會(huì)會(huì)議。


§ Provide project management leadership and
can manage multiple projects at given time提供項(xiàng)目管理領(lǐng)導(dǎo)力，并能在給定的時(shí)間內(nèi)管理多個(gè)項(xiàng)目。


§ Provides guidance to Purchasing, Engineers
and stakeholders in applying supplier quality system requirements. 為采購(gòu)、工程和利益相關(guān)者提供供應(yīng)商質(zhì)量體系要求的指導(dǎo)。


§ Participates in designing, developing and
executing design and manufacturing process validations/verifications and
determines appropriate sampling plans or proactive initiatives for subsequent
routine production. 參與設(shè)計(jì)、開發(fā)和執(zhí)行設(shè)計(jì)及制造工藝的確認(rèn)/驗(yàn)證，確定適當(dāng)?shù)某闃佑?jì)劃或?yàn)楹罄m(xù)的日常生產(chǎn)提供積極的方案。


§ Engage with external customers/contacts
include outside technical contractors, suppliers, consultants, second and third
part auditors, and researchers. Internal
customers may include any or all of the following, New Product Development,
Research, Operations, Marketing, Legal, Sales, Clinical, Human Resources,
Quality and Regulatory departments與外部客戶/聯(lián)系人包括外部技術(shù)承包商、供應(yīng)商、顧問、第二和第三方審核員和研究人員。內(nèi)部客戶可以包括以下任何一個(gè)或全部：新產(chǎn)品開發(fā)、研發(fā)、運(yùn)營(yíng)、市場(chǎng)營(yíng)銷、法律、銷售、臨床、人力資源、質(zhì)量和管理部門。


§ Strong understanding of industry practices,
government reporting and legal matters, and strategic quality initiatives. 對(duì)行業(yè)慣例、政府報(bào)告和法律事務(wù)以及戰(zhàn)略性質(zhì)量方案有很強(qiáng)的理解力。


§ Develops solutions to problems of significant
scope and complexity to which might cause delays to program schedules and may
result in negative financial implications. 提供重大范圍和復(fù)雜性問題的解決方案，這類問題可能會(huì)導(dǎo)致項(xiàng)目進(jìn)度的延遲，并可能導(dǎo)致負(fù)面的財(cái)務(wù)影響。


§ Lead full responsibility for a product
launch and/ or transfers at one of the strategic suppliers領(lǐng)導(dǎo)戰(zhàn)略供應(yīng)商產(chǎn)品的發(fā)布和/或轉(zhuǎn)移。


§ Participates in pre-production activities
for new and transferred products. 參與新產(chǎn)品和轉(zhuǎn)移產(chǎn)品的前期活動(dòng)。


§ Develop and implement efficient and
effective inspection points and control plans at the supplier site. 在供應(yīng)商現(xiàn)場(chǎng)開發(fā)和實(shí)施有效的檢查點(diǎn)和控制計(jì)劃。