北京招聘

职位描述：
Principal Duties and Responsibilities
- Directs quality improvement projects within China to ensure alignment with international standards and local regulations and provides regular communication to Corporate and Regional Leadership on progress in the area of Quality.
- Identify and manage interactions and interdependency of elements within the quality system in multiple manufacturing organizations.
- Lead Post Marketing Surveillance initiatives as per Corporate and CFDA regulatory requirements (Complaint handling, Quality Hold, MDR, Recall).
- Be knowledgeable of the latest regulatory and corporate requirements concerning quality and quality systems and update the necessary processes and procedures in China accordingly, providing regular updates to Regional Leadership as required.
- Directs and facilitates individual and group development to prepare others to assume new, and/or increasing levels of, responsibility.
- Develops and maintains good and healthy working relationships with Regulatory bodies who govern PMS for Medical Devices (SHFDA, CFDA, etc).
- Assure vendor compliance to QAQC standards resulting in products that meet or exceed specifications for product safety, performance and reliability.
- Leads (or co-leads) Quality System inspections by government health agencies, Notified Bodies or Authorized third parties and participates, as appropriate, in external activities conducted by regulatory agencies, trade associations and/or professional societies on issues of interest or concern.

Expected Areas of Competence (i.e. KSAs)
- Candidates preferably a Chinese National and fluent in both English and Mandarin.
- Project Management - will be expected to identify and implement projects with a high impact to the business. As such, should possess proven track record of successful leadership of high impact quality remediation projects.
- Ability to work to provide QA/RC support to ensure regulatory compliance and business strategy.
- Knowledge and experience with Global Quality System Regulations and standards such as CFDA GMP/GSP, ISO 13485, FDA QSR, MDD, CMDR, JPAL and other applicable regulations.
- Demonstrated experience in interpreting and applying regulations and standards for Quality Management Systems that govern manufacturing and distribution of products worldwide.
- Lead and motivate personnel from varied backgrounds and cultures in local and remote locations.
- Ability to achieve productivity goals without sacrificing quality in a manufacturing environment.
- Understands technical aspects of manufacturing operations as they relate to delivery of product meeting specifications and customers’ expectations.
- Computer literacy including Microsoft Office Suite.
- Proven strong oral and written communication and presentation skills.
- Takes accountability, achieves results and develops self and others.
- Strategic thinker with ability to drive product and process improvement.

Education/ Experience Requirements
- B.S. degree in a technical discipline, preferably engineering or physical science, M.S. degree is preferred.
- 5 years’ experience in a position of responsibility for establishing and/or maintaining the quality operations (QA/QC) of a medical device, pharmaceutical or biotechnology industry.
- Manufacturing organization work experience.
- Experience in Quality systems remediation and Six Sigma improvement tools.
- Experience with Lean Manufacturing is desirable.
- Previous working experience in multinational corporations and ability to work in both a matrix and a traditional business organization. International experience is a plus. 举报 分享

捷迈邦美成立于1927年，总部设立在美国印第安纳州华沙镇，是骨骼肌肉保健行业的全球领导者。我们的经营范围包括：设计、生产和营销骨科置换产品；运动药物、生物制剂、肩肘足踝产品和创伤产品；脊椎、骨折愈合、颅颌面和胸椎相关产品；牙科产品；以及手术工具产品。

我们同全球医务人员合作、加速创新。我们致力于提供产品和解决方案帮助患者治疗骨骼、关节或支持软组织疾病。通过同医务人员合作，我们成功给数百万人带去了福音。

我们在全球超过25个国家经营业务，产品销售到100多个国家。关于更多信息，请访问****************或登录推特网关注捷迈邦美，网址***********/zimmerbiomet.

捷迈（上海）医疗国际贸易有限公司自2011年起连续4年被评为中国杰出雇主奖，捷迈注重为员工提供优异的雇员福祉，注重培养发展组织内各级别的人才。

We offer an attractive remuneration package & good carrier development opportunities to the successful candidate. Please send your resume, recent photo, copy of certificates and ID card to the company address.