苏州招聘

职位描述：
Job title QREM
Level Manager
Function Quality & regulatory
Region AP
Location Taizhou
Reporting to Plant GM

Purpose of the position
Set up the quality system and make sure the regulatory requirement for all target market


Responsibilities & duties
Responsibility 1 Act as management representative of plant

Responsibility 2 Establish & maintain the proper quality system in the plant according to all the requirement such as ISO 13485, China GMP, FDA, CE and so on.

Responsibility 3 Set up the quality team in terms of quality system, quality control and regulatory

Responsibility 4 Responsible for product release in the plant

Responsibility 5 Act as window to all related authorities from regulatory point of view, make sure the regulatory conformity of plant.


Academic & Formal Qualifications
Essential qualifications Bachelor degree or above and major in polymer or mechanical engineering; Good written and oral English skills.
Desirable qualifications


Work Experience & Skills
Essential experience At least 8 years of experience in quality functions and at least 3 years of experience on the position of quality department manager; very good sense of quality system set-up and quality control. Very familiar with China GMP and other regulatory.
Desirable qualifications


Personal Qualities & Behavioral Traits
Essential qualities or behaviors Team player, result-oriented, data-driven decision maker, and open-minded.


Desirable qualities or behaviors

Supervision, Direct Reports & Key Stakeholders
Details of supervision relevant to this role For manager him/herself, he/she will manage quality system, quality control and regulatory team. He/she will directly report to plant GM and dot line report to quality director in headquarter.

Approved
Employee signature:
 
Manager’s signature:
  
Date approved:
 

The above description only includes the principle functions and duties which are considered material to the proper identification and classification of the job and if not a limitation of/or restriction upon duties or work requirements that may be inherent in the job. The information listed is not to be interpreted to include all of the details required in the performance of a job.

Sol-Millennium Medical Group is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status 举报 分享

Sol-Millennium是一家专注于一次性医疗器械研发，制造与市场销售的跨国公司。公司总部位于上海徐汇区港汇广场，并在美国亚特兰大，波兰华沙以及巴西圣保罗设有分公司，分别负责亚太，北美，南美以及欧洲的市场拓展，销售与客户服务。Sol-Millennium目前在全球已拥有100多项相关产品的专利技术，为近50个国家的护士与病患提供我们的优质的产品与服务。

Sol-Millennium致力于为我们的客户提供高品质，与众不同的设计的产品，以及本地化的临床销售与便捷物流服务，同时我们也致力于与我们的客户一道，通过持续研发改进，为我们的客户提供更多优质的产品，以进一步满足客户的需求。
2012-2015 SOL-M 连续4年赢取摩洛哥卫生部安全注射器供货竞标；
2011-2015 SOL-M 连续5年赢取巴西圣保罗州安全注射器供货竞标；
2013-2015 SOL-M 连续3年赢取巴西圣保罗市安全注射器供货竞标；
2015 SOL-M 赢取科威特首个安全针供货竞标，这是科威特历史上第一个安全针产品的竞标；
2015 SOL-M 携手 B.Braun 赢取苏格兰 NHS 安全针和钝针产品供货竞标，这是苏格兰历史上第一个安全注射产品的竞标。

我们生产销售的每一支产品都通过了业内质量标准体系的认证，包括 ISO, CE, INMETRO, FDA510(K), TFDA, TGA等等

Sol-Millennium的商业模式：
专注于研发-实现主要产品与市场竞争对手的差异化。
专注于产品线战略-通过不断推出新产品完善产品线，增加客户粘性与忠诚度， 实现营收的稳定与持续增长。
专注于国际化战略-提供本地化营销，便捷物流服务，从而优化细分渠道的拓展， 尽可能贴近客户，降低时间与沟通成本，获取更高的销售利润。同时，SOLM将积极筹划未来的本地化制造，研发与采购战略。
专注于自主品牌建设-并通过与重点客户的合作，可控地发展ODM业务。（目前销售60%自主品牌，40%客户或联合品牌)
专注于自动化制造-其它产品外包制造，加强对供应链，产品质量及成本的控制能力，并提高公司的质量水平和毛利润率。

Sol-Millennium的核心竞争力：
销售渠道-有竞争力的海外销售渠道 – 170家海外经销商，覆盖超过50个国家
质量体系-熟悉美国、欧洲及其他海外国家的医疗器材行业质量体系要求
产品专利-丰富的产品专利 超过100项核心技术专利，足够支持未来5年的新产品上市
合作关系-与行业领先企业保持良好的合作关系，国内唯一通过这些企业质量审核的公司