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概要
Dynamic and results-oriented IT and QA professional with over 4 years of experience in the surgical and medical instruments industry. Proven expertise in managing compliance, quality assurance, and IT operations at leading organizations. Skilled in spearheading certification processes including ISO 9001-2015, ISO 13485-2016, FDA, and MDR, while leading cross-functional teams and driving organizational excellence. Adept at creating and implementing SOPs, managing ERP systems, and enhancing operational efficiency. Seeking to leverage my skills and experience in a challenging role to further broaden my horizons in the tech and medical industries.
项目
工作经历
Assistant G.M
Assisted GM in managing operations for a leading manufacturer of nail, skin, and hair care implements.Led the establishment of an R&D department, enhancing product quality and innovation.Managed store operations, lot movement, and sample room setup.Operated hardness testing machines to ensure product standards.
Compliance and Registration Manager
Directed certification processes, securing MDR, ISO 9001-2015, ISO 13485-2016, FDA, and CFDA certifications.
Managed and implemented SOPs across QA, HR, and IT departments.
Conducted internal audits, employee training, and compliance checks.
Spearheaded the integration and management of ERP software systems.
QA MANGER
Led the implementation of SOPs and QA processes, utilizing software tools to ensure compliance with industry standards.Managed the integration of ERP software, collaborating closely with developers and end-users to optimize HR and QA modules.Conducted internal audits and training, focusing on the use of software for maintaining quality standards.Developed and implemented software-driven processes for HR and compliance management.Collaborated with software developers to customize ERP solutions, enhancing the functionality of HR and QA modules.Managed data migration to new software platforms, ensuring accuracy and reliability in HR systems.
Assistant QA Manager
Led the implementation of SOPs and QA processes, utilizing software tools to ensure compliance with industry standards.Managed the integration of ERP software, collaborating closely with developers and end-users to optimize HR and QA modules.Conducted internal audits and training, focusing on the use of software for maintaining quality standards.Developed and implemented software-driven processes for HR and compliance management.Collaborated with software developers to customize ERP solutions, enhancing the functionality of HR and QA modules.Managed data migration to new software platforms, ensuring accuracy and reliability in HR systems.
