Associate Director, Quality - China
Position Overview
Responsible for all company quality processes in China ensuring compliance to China-specific regulatory requirements. Ensure regulatory compliance to applicable China domestic and international requirements. Integrate activities associated with receiving inspection, in-process inspection, finished product inspection, and product support quality engineering. Work closely with Manufacturing, R&D, Regulatory Affairs, and other Quality Assurance areas to support manufacturing process changes, product design transfers, product sustaining projects, and continuous improvement of product quality. Job duties:
*Must have medical device experience
*Must have medical device experience
- Responsible for all aspects of Quality function related to China.
- Work very closely with the Regulatory Affairs, China team.
- Collaborate with Sales and Marketing teams in US and China related to market priorities and timing.
- Oversee Quality related projects consistent with the company goals.
- Lead the implementation and maintenance of MV Quality Systems in MV China based facilities.
- Represent China Quality Assurance on various design and development teams by attending team meetings and providing the required plans, procedures, and regulatory decisions.
- Advise senior management of action required to meet department objectives.
- Lead prevention-oriented quality improvement programs to meet company quality goals and objectives.
- Lead efforts to establish Quality procedures for all stages of product realization compliant to applicable standards.
- Lead efforts for quality reporting of product-related quality and performance data and apply statistical methods to proactively identify product quality issues and trends. Initiate Corrective and Preventive Actions to ensure product quality and compliance.
- Review and approve procedures designed to ensure successful testing of critical components, sub-assemblies, and assemblies for conformance to specifications and standards.
- Remain informed about developments and trends in quality control and make recommendations for appropriate corrective actions.
- Ensure the quality policy/system is planned, understood, implemented, and maintained within the department.
- Ensure departmental compliance, as well as appropriate departmental resources, are available to effectively maintain the quality system.
- Perform additional responsibilities as assigned.