§ Conduct on-site quality and process
assessments at suppliers對供應商進行現(xiàn)場質量和過程評估。
§ Collaborate with the Manufacturing and
Quality engineers worldwide, in assessing and addressing supplier quality issues與全球的制造和質量工程師合作,評估和解決供應商質量問題。
§ Ensure effective and timely closure on all
Supplier Corrective Action Requests. 確保所有供應商糾正措施及時有效的關閉。
§ Ensure suppliers continue to meet J
Quality requirements with regard to Supplier Change Request process 確保供應商持續(xù)滿足關于供應商變更管理的質量要求。
§ Generate quality metrics on supplier
performance and establish measures to monitor quality costs and avoidances建立供應商績效的質量指標及監(jiān)控質量成本和質量風險。
§ Facilitate the completion of the quarterly
Suppler Management Committee meeting完成季度的供應商管理委員會會議。
§ Provide project management leadership and
can manage multiple projects at given time提供項目管理領導力,并能在給定的時間內管理多個項目。
§ Provides guidance to Purchasing, Engineers
and stakeholders in applying supplier quality system requirements. 為采購、工程和利益相關者提供供應商質量體系要求的指導。
§ Participates in designing, developing and
executing design and manufacturing process validations/verifications and
determines appropriate sampling plans or proactive initiatives for subsequent
routine production. 參與設計、開發(fā)和執(zhí)行設計及制造工藝的確認/驗證,確定適當?shù)某闃佑媱澔驗楹罄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)系人包括外部技術承包商、供應商、顧問、第二和第三方審核員和研究人員。內部客戶可以包括以下任何一個或全部:新產(chǎn)品開發(fā)、研發(fā)、運營、市場營銷、法律、銷售、臨床、人力資源、質量和管理部門。
§ Strong understanding of industry practices,
government reporting and legal matters, and strategic quality initiatives. 對行業(yè)慣例、政府報告和法律事務以及戰(zhàn)略性質量方案有很強的理解力。
§ Develops solutions to problems of significant
scope and complexity to which might cause delays to program schedules and may
result in negative financial implications. 提供重大范圍和復雜性問題的解決方案,這類問題可能會導致項目進度的延遲,并可能導致負面的財務影響。
§ Lead full responsibility for a product
launch and/ or transfers at one of the strategic suppliers領導戰(zhàn)略供應商產(chǎn)品的發(fā)布和/或轉移。
§ Participates in pre-production activities
for new and transferred products. 參與新產(chǎn)品和轉移產(chǎn)品的前期活動。
§ Develop and implement efficient and
effective inspection points and control plans at the supplier site. 在供應商現(xiàn)場開發(fā)和實施有效的檢查點和控制計劃。