Kwan Yew brings over 20 years of extensive experience in Commercial and Manufacturing Quality Assurance, currently serving as the Regional Senior Quality Assurance Manager at St. Jude Medical. In this pivotal role, Kwan oversees the standardization and compliance of the Quality Management System across all...
Kwan Yew brings over 20 years of extensive experience in Commercial and Manufacturing Quality Assurance, currently serving as the Regional Senior Quality Assurance Manager at St. Jude Medical. In this pivotal role, Kwan oversees the standardization and compliance of the Quality Management System across all Sales and Marketing Companies in Asia, excluding Japan. His expertise in regulatory requirements ensures that all operations align with local health authority standards, which is critical in the highly regulated medical device industry.
Kwan's proficiency in Quality Assurance is complemented by his strong background in Quality Control and Product Reliability/Safety. He has successfully led key projects that focus on New Product Introduction (NPI), ensuring that new offerings meet stringent quality benchmarks before reaching the market. His adeptness at setting up Key Performance Indicators (KPIs) has been instrumental in driving continuous improvement initiatives across multi-disciplinary teams, enhancing operational efficiency and product safety.
Kwan is well-versed in industry standards such as ISO 13485 and Good Manufacturing Practices (GMP), and he leverages Six Sigma methodologies to optimize processes and reduce variability. His collaborative approach fosters strong relationships with cross-functional teams, enabling effective problem-solving and innovation. As a leader in the field, Kwan is committed to advancing quality assurance practices within St. Jude Medical, ensuring that the organization not only meets but exceeds the expectations of regulatory bodies and customers alike. His strategic vision and dedication to excellence position him as a key player in the ongoing evolution of quality management in the medical device sector.
