Quality Assurance Manager
CurrentResponsible for China Region Quality Compliance and Quality Control to make sure the high quality of service delivery and business quality management. Data analysis throughout the quality review and business review and set up the quality plan. Procedure and process monitoring and changing to make sure customer feedback is the key focus of the business. Set up NPS KPI and analysis the customer feedback to rule out the business failure.Develop regulatory strategies, templates and documentation for product registrations for each new or modified product.Manage assigned product registration and licensing activities in accordance with China regulations; including filing determinations and submission content.Compile information from multiple sources (e.g., project teams, corporate RA/QA, etc.) for submissions, guiding project teams in creating documentation for submissions, writing summaries and other necessary documentation for submissions.Assist with product safety determinations and vigilance reporting activities.Support product corrections and removals as directed by Corporate.Interface with regulatory agencies on regulatory issuesAssist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products and complying with regulations.Develop and maintain site Quality System policies and procedures to comply with import requirements. Coordinate with site personnel to ensure the success of site audits including site audits of treatment facilities. Drive closure to audit findings including investigation, implementation, and effectiveness checks.