苏州招聘

RESPONSIBILITIES:
Key deliverables for this role are:
? Identification of key process quality factors on key/critical components
? Oversight and evaluation of supplier process qualification and validation
? Assessment and mitigation of product risk associated with the use of product within end product
? Oversight of NPI and for key/critical components
? Development or approve Validation Plans, Protocols and Reports for processes located at supplier sites
? Determination of the effectiveness and adequacy of supplier validations
? Development of DOE models, as necessary
? Support Supplier Quality Engineering with defect investigations, root cause analysis, correction and preventative actions
? Analyze Supplier Capability
? Support Supplier Selection
? Support Supplier Quality System evaluations and audits
? Perform Process Qualifications
? Perform Process Validations
? Identify the use of Special Process in the supply chain and validate those processes
? Engage suppliers in early design development stages
? Champion Df(x) activities with Supplier
? Assist in SCAR and CAPA investigations as a subject matter expert
? Champion and implement early supplier involvement (ESI) in NPI activities
? Assist Supplier Quality in the creation and enforcement of Quality Agreements
? Follow all Departmental and Corporate Policy's Procedures and Work Instructions
? Support design transfer and ECO implementation
? Ability to travel up to 40% of the time

REQUIREMENTS:

? Bachelors' degree, Electrical, or Mechanical engineering.
? CET-4 qualification required. CET-6 or above preferred. Strong written and spoken English capabilities.
? Minimum of 5 years directly related work experience.
? Experience in the medical device industry is desirable
? Knowledge of FDA GMP and 510K, IEC, ISO.
? Six Sigma training and certification (Lean, Green Belt, Black Belt) highly desirable
? Ability to travel internationally
? Available to travel up to 40% of the time
? Excellent analytical skills and technical writing capabilities
? Proficient in word processing, spreadsheet, and presentation software applications
? Strong oral, written, presentation and interpersonal skills
? Be able to interface with multiple disciplines within the organization
? Ability to organize data from multiple sources, extracting key information and writing technical reports with executive summaries
? Experience using data analysis computer tools and statistical analysis tools
? Experience developing and implementing Design Of Experiments
? Strong analysis and problem solving skills; lean manufacturing, six sigma and continuous improvement mindset
? Excellent communications and project management skills; a team player
? Excellent interpersonal skills

Spacelabs Healthcare combines a core of the world’s most respected medical device and services companies. With offices worldwide and distribution channels in over 100 countries, Spacelabs Healthcare has the talent and resources to deliver on its promises of innovation. We connect the needs of caregivers and their patients with real-life integrated solutions. We offer value to our customers through a broad range of products and services that assist you in delivering the highest quality patient care as efficiently as possible.
太空医疗集团整合了世界一流的医疗设备与服务公司，在全球100多个国家建立了办事机构与分销渠道。我们拥有丰富的人才和资源，信守承诺，锐意创新。我们悉心了解医护人员与患者的需要，开发实用的综合解决方案。我们通过广泛的产品和服务，帮助医护人员为患者提供优质、高效的医疗，从而使您的价值得到肯定。

Spacelabs is a focused global innovator and manufacturer of Medical Systems and Services including Patient Monitoring Systems, Anesthesia Delivery and Ventilation, Diagnostic Cardiology, Diagnostic Core Lab Services, etc.
太空医疗是一个全球性医疗设备和服务行业的革新和制造者，这包括了病患监护系统、麻醉系统及心脏诊断等解决方案。

We are a rapidly growing, fast paced and high energy company looking for talented individuals to become part of our global team and to bring technical excellence as we pursue that challenge together. We are an equal opportunity/affirmative action employer committed to work force diversity. We offer salaries commensurate with skill and a comprehensive benefits package.
作为一个快速发展，步伐紧凑、充满活力的公司。我们寻找具有优秀专业技能的人才加入全球团队和我们一起迎接挑战。我们承诺公平用工，并提供具有市场 竞争力的薪资和福利。

In order to support growing business in China, we invite you to join us and build our future together!
伴随我们在华业务的成长，诚邀您加入太空医疗和我们共同构筑未来!