Sr. Quality Engineer

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

在我们的信条指引下，强生公司对全球范围内与我们共事的员工负有责任。我们提供一个包容的工作环境，在这里每个人都被视为独立的个体。在强生，我们尊重员工的多样性和尊严，并认可他们的价值。

工作职能：Regulatory Affairs Group

作业子功能：Regulatory Affairs

职位类别：Professional

所有职位发布位置：Shanghai, China

职位描述：
DePuy Synthes is recruiting for a(n) Sr. Quality Engineer, located in Shanghai, Shanghai, China.

This role supports China operations and distributor management activities within Quality & Regulatory Affairs (QARA), ensuring compliant, efficient, and reliable execution of operational and distribution processes. This role partners closely with internal cross‑functional teams and external distributors to maintain regulatory compliance, support product availability, and drive continuous improvement across China distribution operations. This position plays a critical role in protecting patients, customers, and the DePuy Synthes brand while supporting business growth in a complex regulatory environment.

Key Responsibilities

Lead complaint/Potential Adverse Event /suspected diversion or counterfeit case/Legal case management.

Act as contact window between global and local operation company, implement Product Recall activities to compliance with China regulatory, company policy and Local quality management system requirements.

Work together with global PMS to complete vigilance related reports per China regulation and company requirements, including but not limit to periodic risk evaluation reports (PRER), risk signal report and etc.

Responsible for special monitoring program, risk evaluation report, VBP report, adverse events from Health Authority system directly.

Support on AE investigation to ensure compliance related to government/health authority regulations.

Support regulatory and quality audits, inspections.

Identify and support continuous improvement initiatives to enhance PMS efficiency and compliance.

Qualifications

Education

Bachelor’s degree required, preferably in Life Sciences, Engineering, Supply Chain, Quality, Regulatory Affairs, or a related field.

Advanced degree preferred (e.g., Master’s).

Experience and Skills

Required:

Typically 4–6 years of relevant professional experience in Quality, Regulatory Affairs, Operations, Supply Chain, or Distribution Management within a regulated industry (e.g., medical devices, pharmaceuticals, healthcare).

Working knowledge of China regulatory and quality requirements related to product distribution and post market surveillance.

Ability to work effectively in a matrixed, cross‑functional environment.

Preferred:

Experience supporting QARA or compliance‑driven operations within a global organization.

Familiarity with audits, inspections, CAPA, and continuous improvement methodologies.

Experience working with global or regional stakeholders across time zones.

Hold a certificate in adverse event reporting training

Strong analytical, documentation, and problem‑solving skills.

Other:

Language: Fluency in Mandarin and English required.

Travel: Limited; Up to 10–20%, primarily within China.

Certifications: Quality or Regulatory certifications (e.g., ISO, internal auditor) preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:
保密, 产品授权, 法规遵从, 法律支持, 分析推理, 风险评估, 沟通, 监管环境, 监管开发, 监管事务管理, 解决问题, 商务写作, 商业行为, 数据报告, 团队合作, 细节导向, 药品和器械研发与监管