Areas of Responsibilties:
? Be responsible for ensuring manufacturing transfer/design transfer activities be compliance with NMPA design control requirements.
? Lead risk management activities in China including driving risk management files establishment, reviews and updates.
? Responsible for process Non-conformance/Deviation/Change/CAPA from materials, process, and finished products, and coordinating local Quality Review Board activities
? Be responsible for Post Market Activities including all complaint, Product Holde Communication Tool, Adverse Event reporting, Field Action, Annual Product Reporting etc.
? Be responsible for the final product release.
? Lead and train the quality system management and quality assurance team members
? Provide quality assurance supports to other cross functional teams, e.g. production, technical, engineering to ensure activities comply with QMS requirement and local regulations.
? Integrate of Siemens Healthineers global and local quality system requirements into a China quality management system that is compliant with NMAP requirements, with an emphasis on the following QS processes eg. CAPA,Internal audit,External audit, mainly from NMPA and corporate, DHR review,documentation and training etc.
? Manage Quality Objective follow up and support QMR for Quality Management Review
? Drive QMS continuous improvement for China facility.
? Lead registration on-site audit preparation and main manufacturing license.
? Support engineering team on specific equipment, facility and utility validation protocols and reports.
? Support all qualification/validation plans, protocols and reports are complete, accurate and compliant with applicable requirements, including those of the China FDA.
? Support technical dept. to review all technical plan/report to make sure the compliance.
? Be responsible for recruitment and training of the QA