Sr. Quality Engineer

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: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Shanghai, China Job Description: 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.

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.

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.