南京招聘

Responsibilities:

The position is accountable for regulatory compliance and quality system management within supply chain/warehouse quality management. This person will be the point person and accountable for execution of medical device GSP related regulation requirements in support of supply chain/warehouse quality management. S/he will support the regulation and quality system objectives and strategies, regulatory and compliance requirement changes.

• Be responsible for on-site products quality assurance activities in warehouse, including but not limited to new product launch compliance, NC product handling, inventory transfer review, return product review and product scrap approval.

• Perform product final release to ensure all products released to the field from China warehouse are fully comply with both China regulatory.

• Be responsible for new product launch readiness review to ensure the product is compliant with regulatory requirements and all necessary supporting materials are ready to launch the product.

• Plan and conduct the analysis, investigation, inspection, and/or disposal of product nonconformance.

• Be responsible for inventory transfer approval (PHO, NC, return products)

• Be responsible for return product review before release back to warehouse

• Provide support to external inspection from local authority.

Requirements:

• Education

  Junior college or above, major in medical device, biomedical, engineering, mechanical, medical, chemical, pharmacy, management or related.

• Experience

  1-3 years of medical device or pharmaceutical industry experience, warehouse, quality or test related working experience preferred.

• Competencies

• Familiar with medical device or pharmaceutical GMP/GSP and relevant regulations.

• Prior knowledge and understanding of the medical device, pharmaceutical or equivalent regulated industry, quality systems (eg. ISO 13485) is preferred.

• Effective communicating and coordinating.

• Normal Microsoft office skills and available in reading and writing English.

• Character

Integrity, initiative, faster leaner and team player.

KARL STORZ公司1945年成立于德国西南部的图特林根市。经过70年的发展，目前已超过6400名员工，成立有50个分公司，在全球39个国家和地区设立有办事机构。产品销往全球超过150个国家和地区，营销网络遍布欧洲、美洲、亚洲、澳洲、非洲。公司业务线包括：人体医用微创设备和器械、工业内窥镜、兽医用微创设备和器械。经过全体KARL STORZ人的努力，我们已经是：
业界***一家生产全科内窥镜产品的公司
全球***微创外科内镜设备及器械制造公司
   
自2006年进入中国以来，已在上海、北京、广州、成都、沈阳、南京、西安和香港等地开设了办事处，服务于大中华区的客户。经过近10年的奋斗，KARL STORZ中国区同样硕果累累，在中国大陆地区取得的市场荣誉包括：
进口内镜品牌市场占有率***，获得中国手术内窥镜市场增长奖
一体化手术室市场占有率超过50%，获得中国一体化手术室市场领导奖
中国硬式内窥镜类售后服务满意度***名

作为专注于产品的家族企业，KARL STORZ一直致力于开发外科新产品，源源不断地将各类精密产品和优质服务推向全世界。同时通过和医学各学科的领军人物、各医科大学和科研机构人员接触并进行专业对话，不断革新微创产品、发展微创技术，为医生和病人的需求提供理想的解决方案。虽然锐意进取，但在国内和国际的竞争中，KARL STORZ始终奉行“以客户为重、质量先行”的宗旨，抵制所有的非法行为。

如果具备以下特质，欢迎您的加入：
突出的个体贡献者：在现有岗位上取得优异的业绩
积极的协作者与促进者：对周围同事提供支持和帮助，对组织创造价值
优秀的管理者：成功培育人才，带领团队产生高绩效
KARL STORZ公司将为优秀人才提供：
医疗行业内富有竞争力的薪酬福利体系
更多的学习发展机会
更多的岗位选择机会

投递简历后，如符合岗位要求，HR将于4周内联系您。如暂时没有合适您的职位，您的资料将自动转入人才库。在12个月内，如有合适的职位，HR仍有可能联系您。

Company:
Since its beginnings in 1945, the KARL STORZ family company has grown into a global manufacturer and distributor of endoscopes, medical instruments, and devices. They are not a giant on an international scale but a leader in the things that matter: creativity, flexibility, and expertise. The company’s endoscopy equipment includes over 15,000 products used in human and veterinary medicine as well as in industrial applications. The diversified product portfolio augments the company’s ability to register market leading growth by providing multiple sources of revenue. The most recent KARL STORZ developments are in digital documentation systems and comprehensive operating room concepts. As a system supplier, the company combines its expertise in endoscopy with software solutions to achieve integration in the operating room and to support clinical process and resource management. The company headquarters in Tuttlingen, Germany.

Products & Operations:
When KARL STORZ started to take an interest in endoscopy about 70 years ago, few specialties used endoscopes. That has changed radically. Thanks in part to dedicated KARL STORZ development work throughout recent decades, virtually every medical specialty can today benefit from endoscopic and minimally invasive procedures. The overview of the product range therefore literally reaches from head to toe, and with a steadily growing portfolio, it also extends to the large sectors of veterinary medicine and industrial endoscopy.
As a global family company, KARL STORZ is active worldwide to support and consult customers around the globe. Across all continents, KARL STORZ is represented by more than 50 KARL STORZ subsidiaries in 39 countries.
KARL STORZ China’s Head office is based in Shanghai along with branches in Beijing, Guangzhou, Chengdu, Shenyang and Hong Kong. As part of its international market, KARL STORZ China has experienced significant growth over the past five years, and will continue to grow.
To learn more about KARL STORZ and their product offerings, please visit their website at ************************/.