Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

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:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing