Quality Specialist

Shanghai - China

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Shanghai China

Job Description:

SECTION 1: JOB POSITION SUMMARY 第一部分工作概要

Job Title 职位名称: CQ Senior Specialist 商业质量高级专员

Scope 范围: JJVC China CQ 强生视力健中国商业质量

Support and maintain JJVC marketing company quality management system effective continuously in accordance with applicable regulation and standards.支持和维护强生视力健中国营销公司质量管理体系持续有效以保证符合相关法规和标准

Monitor external regulation and ensure company QMS compliance with local regulation. 监测外部法规环境并保证公司质量体系的合规性

Coordination of Internal & External audit self-inspection reports per local GSP regulation. 协调内审/外审组织质量体系自查以保证满足医疗器械经营质量管理规范的要求 Coordination of quality training. 协调质量培训

Be responsible to local PMS responsibilities including Field Action National Sampling complaints and Adverse Events etc. 负责后市场相关活动的开展包括现场行动国抽投诉及不良事件等

Coordination of local UDI activities per China regulation. 根据中国相关 UDI 法规开展本地 UDI 工作

Support on quality inquiries from local market. 支持本地市场的质量相关问询 Other tasks assigned by Manager. 经理分配的其他任务

SECTION 2: DUTIES & RESPONSIBILITIES 第二部分工作职责

Perform regulation gap assessment and follow up activities to ensure company QMS compliance with local regulation. 负责实施法规分析针对差异开展后续活动保证公司质量体系符合法规要求

Draft and update the related quality procedures ensure effective operation of QMS in accordance with medical device GSP regulations. 起草并更新质量相关程序文件保证质量体系有效运行且保证满足医疗器械经营质量管理规范等法规的要求

Be the role of coordinator to collaborate with internal cross-functional team for preparation for internal and external audit. 组织及协调公司内部跨部门团队准备及应对内部及外部审计 Be the role of coordinator to collaborate with local and global SMEs to work on annual self-inspection report for both local and overseas Legal Manufacturer. 组织及协调内部及总部跨部门团队完成医疗器械境外注册人年度自查报告医疗器械经营企业年度自查报告

Be responsible for renewal and maintenance of the Medical Device Distributing License. 负责公司医疗器械经营许可证的办理延续维护

Be the role of the training coordinator to assign the training in system and follow up the completion of the training; perform the onsite process/procedure training when required. 作为本地培训协调员管理通过系统发出的培训跟进培训完成情况并根据需求开展现场培训

Coordination of complaint intake and evaluation both locally and in cooperation with manufacturing plants for investigations. Perform the complaint reporting training when required. 协调及支持投诉报告录入及评估支持本地及总部工厂的投诉调查根据需要开展产品投诉培训

Be responsible for the field action or product recall internal coordination and reporting. 负责现场行动或产品召回的实施协调报告

Supports on sales inquiries and provide regulation supports as applicable. 支持本地销售问询并提供必要的法规支持 Other tasks assigned by Manager. 经理分配的其他任务

SECTION 3: EXPERIENCE & EDUCATION 经验&教育

Education Requirement: have an educational background above college degree or above in majors (including medical devices biomedical engineering machinery electronics medicine biological engineering chemistry pharmacy nursing rehabilitation laboratory science IT law and administration) or an intermediate professional title or above. 具有医疗器械相关专业包括医疗器械生物医学工程机械电子医学生物工程化学药学护理学康复检验学计算机法律管理学等专业大专及以上学历或者中级及以上专业技术职称

Industry experiences: should have more than three years of work experience in quality management of medical device operation. 并具有 3 年及以上医疗器械经营质量管理工作经历Nice to have

SECTION 4: REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES AND AFFILIATIONS 第四部分必备的知识技能能力证书/从业资格证书以及其他相关的要求

Position experiences: experience in GSP. Preference manufacturing site and GMP working experience and ISO 13485 岗位经验GSP 经验如有工厂相关 GMP 经验和 ISO13485 证书优先

Language Skills: English level is at or above CET-6 skilled in oral and written English 语言能力英语六级及以上具有英文沟通及写作能力

Computer Skills: Familiar with the MS software knowledge of Excel for the data analysis power point for the monthly presentation SAP experiences is preferred 计算机技能熟练掌握 MS 各个软件可以使用 Excel 进行数据分析PPT 进行演讲具有 SAP 经验者优先 Other Special requirement: Strong in skills for communication with different parties independent problem-solving ability self-driving active to learning and manage change etc. 其他要求具有较强的多方沟通技能独立解决问题的能力自我驱动主动学习和应变能力等

Required Skills:

Preferred Skills:

Required Experience: