北京招聘

Job Summary

· To responsible for product registration on recon assigned project.

· To maintain relevant QA work for database, Label and IFU maintenance, on-site inspection.

· To handle responsibility for recall, customer complaints and adverse event.

· Internal audit base on GSP requirements, quality management documents revision.

· To assist and support other related duties for RA/QA Dept.

Principal Duties and Responsibilities

% 50 § Responsible for assigned QA duties. Such as Label and IFU database maintenance and on-site inspection, UDI System and insurance system database maintenance, internal audit, relevant QA duties. 20 § Product recall, customer complaints and adverse event report, product destruction supervision, quality management documents revision and update. 15 § Responsible for assigned segment of i medical device products register in china, include initial and renewal registration, registration changes, IFU filing at NMPA make sure submission is correctly and timely. 10 § Familiar with relevant regulation & policy in QA/RA field. 5 § Provide regulatory support to co-departments or teams in explaining Chinese regulation and give input base on the requirement. 100 Total Percent (not to exceed 100%) *Individual percents should be greater than or equal to 5%.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e. KSAs)

§ Effectively managing one’s time and resources to ensure that work is completed efficiently.

§ Actively participating as a member of a team to move the team toward the completion of goals.

§ Good teamwork and actively attitude

§ Good communication skill.

Education/ Experience Requirements

§ Bachelor or master degree or above in biological or related sciences.

§ Above 3-5 years working experience on QA in the field for medical device.

§ Professional knowledge on regulatory affairs field.

§ Computer skills and be proficient with commonly used software.

§ Good at written and oral in English.

Travel Requirements

20%

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.