Overview
Quality Manager（质量管理主管） Jobs in Shanghai, Shanghai, China at 华新集团
Title: Quality Manager（质量管理主管）
Company: 华新集团
Location: Shanghai, Shanghai, China
该职位来源于猎聘 Your Tasks
- Act as the legally designated Quality Responsible Person toward Chinese authorities and ensure continuous compliance.
- Act as the main contact for the German headquarters for all quality and regulatory matters and coordinate related reporting and alignment processes.
- Establish, implement, and maintain the medical device distribution QMS in line with group-wide and Chinese regulatory requirements (such as mandatory quality and traceability records, supplier qualification, product approval, and ongoing compliance of marketed medical devices).
- Ensure end-to-end traceability through compliant computerized information and reporting systems.
- Ensure quality oversight of storage, zoning, environmental conditions, and outbound verification.
- Manage non-conforming products, recalls, adverse events, and quality complaints in compliance with regulations.
- Plan and ensure quality and regulatory training for all quality-relevant personnel.
- Lead and support quality self-inspections, regulatory inspections, audits, and follow-up corrective actions.
- Support the General Manager in the operational implementation of the corporate and group strategy as defined by German headquarters. Your Profile
- Minimum 3 years of hands-on experience in medical device quality management – preferred in an international or group environment with European or US companies
- Experience in medical device distribution/operation, preferably including Class III products.
- Degree or higher in a medical device–related discipline (e.g. Basic medicine, Clinical medicine, Dentistry, Nursing, Pharmacy etc.)
- Practical exposure to Chinese medical device regulations and authority inspections.
- Fluent in both Chinese and English, written and spoken; German language skills are an advantage
- Organization, accuracy, reliability and ability to work in a team is prerequisites for performing this role
- Familiarity with ERP systems (as Kingdee) and MS-Office Solutions
- Structured, analytical and reliable working style with strong coordination skills
- High level of discretion, accuracy and compliance awareness
- Resident in Shanghai
- Availability: Immediate
