常州招聘

职位描述：
KEY AREAS OF RESPONSIBILITY:
?Responsible and accountable for the planning, leading, execution and post-processing of supplier process, product and QMS audits. You will ensure a dynamic audit process such that audits can focus on process and QMS, thus meeting compliance and product quality requirements.
?Identify and communicate issues that may impact product quality, system gaps or business continuity and ensure these issues are effectively and promptly contained and addressed.
?Complete audit reports and communicate with internal teams and suppliers within the time frame per internal procedures and ensure all audit findings are effectively contained and communicated to supplier and internal partners.
?Accountable for post audit activities including timely closure of all audit deficiencies.
?Maintain supplier audit files and ensure all records are filed on time per procedure requirement and are compliant to defined requirements.
?Work closely with the SQM Partners in order to continuously improve the product quality, delivery and systems at the supplier base.
?Accountable for audit metrics to ensure compliance per procedure requirements and objectives.
?Develop/modify the audit process, procedures and audit checklists as regulatory requirements change or as a result of continuous audit process improvement.
?Participate in Business Development activities like Mergers & Acquisitions and perform due diligence audits.
?Create and foster a strong working relationship with the different Global Supplier Quality functions, Strategic Sourcing and additional key interfaces to facilitate effective collaboration.

QUALIFICATIONS KNOWLEDGE SKILLS :
Professional Requirements- Required:
?Bachelor’s Degree in Engineering or Science fields
?Minimum of 3 years’ audit experience in regulated manufacturing environment.
?Strong working knowledge of QMS and process audits
?Lead Quality Auditor Qualification/Certification in ISO13485 or comparable industry standards and regulatory requirements. Furthermore you are familiar with GMP, ISO 13485, 21 CFR Part 820 standards.
?Demonstrates ownership of and ability to lead multiple tasks to prioritize and complete supplier’s audits in a timely manner and within budget
?Must demonstrate strong ability to work independently to effectively work to meet audits timelines and reporting requirements
?Must demonstrate the ability to plan, organize and implement multiple concurrent tasks
?Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
?Fluent written and oral English

Professional Requirements- Desirable:
?Preferred audit experience with aviation, aerospace, automotive, defense as well as medical device industries
?ASQ CQE/CQM/PE certification
?Experience in Tissue Banks and test Laboratory Systems/ process audits

Personal Competencies
?Demonstrated strong influencing and communication skills.
?Demonstrated professional manner and effective interpersonal skills with an ability to overcome language and cultural barriers
?Highly motivated and able to build close relationships internally and externally.
?Demonstrated responsibility and ability to plan, organize and implement multiple concurrent tasks
?Highly flexible and willing to travel in support of business needs, up to 70% travel is required to different geographical locations 举报 分享

我们，来自美国！
我们，创建于1941年，并已发展为全球规模最大、技术最为领先的医疗技术公司之一！
在全球拥有29个生产和研发基地；
在全球100多个国家和地区销售产品；
拥有近22000余名优秀的员工！
2013年全球业务超90亿美金，并连续32余年保持业务增长——平均每年增长19%！
在骨科植入物、手术介入治疗设备、医疗通讯、数字化影像系统等医疗领域引领技术创新
2012在《财富》５００强中排名第308位，并在由《财富》评选的“最受敬仰的医疗设备及其它精密设备行业”
      中排名第６！
我们，多次荣获盖洛普公司评定的“***工作场所奖”
我们，曾于2005－2008年连续4年获得医疗产品和医疗器械行业“最受尊敬企业”荣誉；
我们，曾于2007－2009年连续3年被授予盖洛普“***雇主奖”
我们，被《中国医疗设备》评选为“2010年优秀售后服务商第2名”
我们，于2011年被《福布斯》杂志授予全球“最具创新力”公司；
我们，于2010-2013连续4年被《财富》杂志授予美国“***工作场所奖”；
……
这，就是史赛克医疗技术有限公司！

史赛克（苏州）医疗技术有限公司成立于２００７年１１月，位于苏州工业园区出口加工区a区，为史赛克集团在亚洲投资的第一个制造工厂，公司将快速成长为集团最大的综合性生产基地之一、并肩负起为集团全球业务供应众多优质治疗产品的使命！
在史赛克苏州，
我们有一个激情洋溢、追求卓越的团队；
我们为员工提供极具竞争力的薪资报酬；
我们致力于创造优质的医疗产品，以帮助人们更为健康、快乐的享受生活！

如果您正在寻找一份与众不同的工作经历，来吧，加入史赛克！

在史赛克，你的天赋将不断地被发现、强化和运用！


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