上海招聘

Duties & Responsibilities

• Provide management oversight of the Smiths Medical Operations Quality (Article Quality Assessments, Control Plans, Process Capability, Customer Complaints, etc) activities across our regional factories to ensure appropriate quality levels across the product franchises. Formulate and drive manufacturing quality excellence programs designed to assure maintenance of the Company’s competitive position and profitability of its manufacturing operations. Collaborate cross-functionally, assuring goal alignment, with other members of the senior management team to include Marketing, Business Development, Sales, Operations, Operations Engineering, Program Management, and Regulatory Affairs & Quality Systems.

 

• Critically analyze, using appropriate sources of data, Smiths Medical operations capabilities; setting strategy, structure, and processes to drive sustained quality improvement in local manufacturing facility.
• Lead manufacturing and supplier quality initiatives to ensure Smiths quality standards are consistently achieved and maintained. Ensure that processes are sufficiently capable to deliver and maintain Smiths quality standards, and develop action plans using cross functional teams to address weaknesses or deficiencies. Develop and implement policies and processes to ensure Smiths quality standards are detailed, robust, communicated and measured consistently throughout internal manufacturing sites and external suppliers.
• Develop world class, common systems for completely integrating Quality Management Systems with Operational processes and the Smiths Operating System. Develop key metrics and scorecards to measure quality level performance within the manufacturing facility.
• Align site and quality objectives with the Business Plan, Operations Objectives, and the Global Manufacturing Quality System to assure effective and efficient use of resources and manufacturing quality excellence.
• Set facility level Quality operations goals and objectives for customer focused quality initiatives. In particular analyze customer complaint trend data and set strategies, structure and processes to drive improvements in operations quality.
• Collaborate with NPI teams to ensure that quality attributes, manufacturability and lessons learned from existing products (e.g. production performance, quality problems, complaints) are integrated into the design and manufacturing processes.
• Provide management oversight of supplier quality, design quality assurance, product registration and regulatory affairs working with related members.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

The Individual：

• Bachelor’s degree in Science or Engineering from an accredited college or university. At least 10 or more years of experience in operations, quality or research and development (preferably in device/drug or biomedical area) with 5 or more years at a senior level.  Masters degree in Science or Engineering is preferred. 
• Experience productively interfacing with marketing, business development, engineering, manufacturing, quality, and regulatory functions.
• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development and engineering.
• Expertise with the domestic and international medical device regulatory environment including the CE Mark, 510(k)/PMA process and approvals, FDA audits and review, design control documentation and internal guidelines.
• Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent
• In-depth knowledge of state, federal and corporate policies/standards (GMP, ISO 9000, SOPs, etc.)
• Knowledge of high volume, state of the art manufacturing processes, preferably in the medical device industry.
• Effective leadership skills and ability to influence department and peers, as well as be a team player
• Excellent verbal & written communication skills (internal & external customers)
• Knowledge of finance and accounting business functions.
• Multi-site and multi-regional research and development leadership exposure and success.

史密斯集团是一家跨国技术（工业）企业，并已于伦敦证券交易所上市。在提高安全性、保护健康和提高生产率的先进技术实际应用方面，本公司位列全球领导者行列。我们将技术带入生活，并致力于打造一个更安全，更健康，更卓有成效的世界
史密斯集团拥有22000多名员工，集团下面的五个分部（John Crane、Smiths Medical 、Smiths Detection、Smiths Interconnect 和 Flex-Tek）经营范围遍布全球50多个国家。160多年来，本公司始终走在技术的最前沿，本公司的产品和服务每天都与数百万人的生活息息相关。
我们将最尖端的技术融入了创新性解决方案的设计、制造中，使这些解决方案达到客户需求。从医疗保健、能源及石化，到威胁与违禁品检测、电信和设备制造——在各个应用和终端市场中，我们都贯彻着这一点，我们的产品和服务对客户的经营往往至关重要，同时，我们的专利技术和高水平服务也帮助客户创造竞争优势。
各个分公司都具有高度的竞争优势，强大的技术实力，在各自的经营领域有巨大的发展空间。凭借高品质品牌、深谙客户与市场、设计符合客户具体需求的能力与售后服务的技术专长，以及坚定不移的经营责任感，各个公司团结一心，强强联合。
John Crane
一流的产品和服务提供商，面向全球能源服务客户。在挑战重重的操作环境中，本公司的解决方案可帮助确保任务关键型设备操作的可靠性。
约翰克兰科技（天津）有限公司成立于2008年，由约翰克兰（天津）有限公司和约翰克兰鼎名密封（天津）有限公司合并组成，公司经营范围包括机械密封、干气密封、高性能联轴器、密封支持系统等相关产品，产品符合A P I 6 1 0 、A P I 6 8 2 、B S 5 2 5 7 、ISO3069、DIN24960及ANSI等国际国内标准。整合后的约翰克兰科技（天津）有限公司能够高效利用全球研发、设计与工程人才，通过为客户提供全球性运营平台，充足的生产和试验能力可以更高效地提供客户所需产品和服务，缩短交货期。另外约翰克兰中国还能够提高服务中心支持能力，通过更多更专业的服务工程师向用户提供全天候的专家咨询和现场技术支持，并向当地用户提供完善的密封修复与试验
Smiths Medical
一流的医疗设备和耗材供应商，这些设备耗材在全世界的患者护理工作中都至关重要。本公司产品包括输注系统、血管通路、重症护理和特型产品。
在 Smiths Medical，我们致力于通过高质量、创新的医疗设备及服务，改善并拯救病患生命。 我们是全球领先的专业医疗设备制造商，为世界卫生保健市场提供创新的救护解决方案。 我们专营注射治疗、血管通路、重要护理和专业产品与服务，产品供应医院、急救中心、家庭和专业护理环境中，用于急救护理和重症监护、手术、术后护理以及慢性疾病管理支持。
主要经营地区
本公司在 30 多个国家设有分支机构，制造主要集中在美国、英国、墨西哥、意大利、德国、捷克共和国和中国。 产品远销约 120 个市场，美国是我们最大的单一市场，约占销售额的 45%，同时，我们继续不断开拓发展中市场和新兴市场。
客户与分配
近四分之三的最终用户客户为医院，其余为替代治疗护理市场，包括家庭护理、诊所和其他外科中心，同时还包括原始设备制造商业务。 产品直销至 20 多个国家，在另外约 100 个国家分销。
Smiths Detection
全球领先的传感器设计商和制造商，这些传感器用于检测和辨别爆炸物、麻醉药、武器、化学制剂、生物危害品、核与放射性物质，以及违禁品。
史密斯·探测（Smiths Detection）公司是英国史密斯集团子公司，是全球最大的安全探测生产商，产品涉及金属检测、识别爆炸物、化学和生物制剂、辐射和核威胁、武器、毒品和走私等领域覆盖全球民用和军用市场业务，全球市场占有率第一。
史密斯·探测（Smiths Detection）致力于设计和制造用于探测和识别包括爆炸物、化学制剂、生物危害、核武器、辐射、麻醉毒品、武器和禁运品等各种威胁的先进系统和解决方案。该公司为客户制造专用产品和管理各种计划，其客户包括美国国防部和国土安全部。在提供分层安全技术方面是全球市场领导者，其美国总部位于马里兰州埃奇伍德，与美国联邦政府和州政府机构及急救机构开展合作，以增强国土安全及保卫军队。该公司是先进技术实际应用领域的全球领导者Smiths Group的独资经营子公司。Smiths Group在全球各地拥有约23,000名员工，其中在美国的员工有9,000多名，在美国40个州约100处营业点开展业务。
Smiths Interconnect
电子设备组件和分支系统的顶尖供应商，这些组件和分支系统用以连接、保护并控制无线通信、航空航天、国防、空间、测试、医疗、铁路、数据中心和工业市场中使用的关键性系统。
Smiths Interconnect 隶属于史密斯集团(Smiths Group)，一家拥有160多年发展历史，全球领先的高科技跨国公司。史密斯集团拥有五大核心业务：健康医疗、石油化工、探测恐怖威胁与违禁品、通讯与半导体、航空与交通。史密斯集团业务遍布全球50多个国家，共有22000名员工，史密斯集团是英国伦敦交易所上市公司，也是英国百强集团之一。

Flex-Tek
Flex-tek是提供加热和运输液体与气体的成型组件的全球供应商，产品主要用于航空航天，医疗，工业，建筑，家用电器领域。