北京招聘

SUMMARY
Plans, organizes, directs and reports on all supplier quality-related activities in Asia Pacific such as raw materials, contracted designed and manufactured items, packaging materials, good manufacturing practices (GMP) service providers, and laboratories to assure procurements meet or exceed the requirements. Monitors quality control activities and systems at supplier and subcontractor facilities. May administer a certified supplier program. May also audit third party manufacturers, due diligence and vendor selection process. May perform deviation investigations into quality issues.


KEY RESPONSIBILITIES

·Responsible to ensure that products manufactured will conform to corporate and applicable regulatory requirements (MDD 93/42/EEC, ISO13485, 21CFR 820, CMDR and applicable local regulations). Also responsible to ensure that products released to the marketplace meet requirements and operations are conducted in an acceptable and efficient manner.
·Executes short and long term objectives for the sub-set function (i.e. design, validation, calibration processes, supplier, six sigma, integration programs).
·Works closely with suppliers to ensure the right parts meeting specifications are delivered on time.
·Ensure operational, functional and compliance excellence.
·Works closely with cross-functional teams across departments including senior management levels to ensure we are doing business with high-quality suppliers and providing appropriate feedback to our suppliers.
·Develops / provides significant supplier input for new products, in collaboration with manufacturing, R&D and Marketing.
·Active participant in regard to suppliers for Design Control and improvement projects to ensure compliance to product specifications, customer requirements and quality systems requirements defined by Haemonetics, the FDA and other regulatory authorities.
·Recommends and evaluates new suppliers to grow the business and improve operational efficiency and quality levels.
·In conjunction with corporate Quality System, reviews customer complaints to determine corrective action in regard to suppliers.
·Participates in risk management activities to identify, design and process risks and ensure mitigation in compliance with corporate procedures in regard to supplier activities.
·Leads teams/projects related to supplier complaint investigation, CAPA, cost reduction and quality system excellence. Deploys TQM tools including six sigma.
·Conducts external supplier audits as assigned to ensure QMS compliance.


EDUCATION, EXPERIENCE, & SKILLS REQUIRED

·Bachelors degree in Quality/Engineering or Life Science discipline
·+6 years of quality assurance / supplier quality engineering experience.
·Proven records of successful cross functional/regional projects
·Proven experience in conducting QS audits, knowledge of current global regulations
·Green/Black Belt six sigma desirable.
·Strong problem solving skills
·Computer knowledge and experience with Microsoft Office
·Good written and oral skills in both Chinese and English
·Travel: 40%

唯美（上海）管理有限公司是美国血液技术公司（Haemonetics Corporation）在中国境内设立的子公司。我们的产品组合包括器械、信息管理和咨询服务，针对血液供应链的所有环节 － 从血浆和血液采集机构到医院 － 提供血液管理方案。 我们坚信，通过合适的血液管理，我们的产品和服务能更好地帮助客户让不用输血的患者不输血，让需要输血的患者输合适的血。
我们的成功始于 1971 年，从那时起，我们提供的设备和耗材就改变了血浆和血液采集中心以及手术室采集和处理血液的方式。 随着行业需求的变化，我们从专注于血液处理系统的医疗器械公司，成为全球领先的血液管理方案供应商。