The regulatory compliance team is responsible for establishing and maintaining quality management system for medical device and IVD to meet GSP (Good Supply Practice) regulatory requirements. The QMS management role will assures that the Quality System, process, resources adequately support the activities and priorities in order to provide an effective and efficient quality system that creates customer value by addressing elements critical-to-compliance, Business success, continuity and competitive advantage.
- Build and improve a mature Quality system for MD/IVD trading to control Quality alignment and execution with China quality related regulations (GSP), ISO 13485, CTC Quality Manual and Corporate Procedures.
- Support Compliance manager to implement GSP for MD/IVD trading control in the company.
- Support Compliance manager by conducting periodic QMS management review and following actions.
- Lead and organize audit program for MD/IVD in CTC both internally and externally, as well as audit of vendors and dealers.
- Builds an influential and effective Network and communication with Supply Chain and other key functions as appropriate, in order to escalate and resolve issues.
- Support on ISO 13485 certifying to CTC MD/IVD trading. (2017)
- Bachelor degree.
- 5+ years’ experience in the Medical Device industry or associated manufacturing or service industries.
- Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to China GSP, 21 CFR 820, and ISO 13485.
- Thorough understanding of quality science, knowledge of continuous improvement methodologies, knowledge of quality systems
- Excellent communication skills
- Excellent track record of cross functional engagement.
- Problem identification, analysis, providing solutions
- Fluency in English both on speaking and writing to fulfill daily communication with global team.
- QMS experience in MD/IVD trading company or CFDA licensed 3PL.
- ISO 13485 internal auditor.