Sr. Quality Engineer

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.