Responsibilities:

• In-charge of factory production operation, QA, PE, PMC & Compliance functions
• Drive and execute strategies as well as business plans to achieve company goals
• Lead and drive the team to improve quality and productivity
• Set up and execute QMS to ensure operation and production procedures are complied with regulatory standards and requirement (FDA / ISO13485)
• Contribute to build a solid & elite organizational platform for the Company to anticipate the fast growth & expansion plans
• Manage quality and regulatory documents (FDA / ISO13485)
• Formulate & implement production traceability system
• Perform ad hoc duties as assigned

Requirements:

• Degree in Manufacturing Engineering or relevant disciplines, Master degree is a plus
• Minimum 15 years practical experience in manufacturing of personal healthcare and medical-care industry, of which at least 10 years in managerial position
• Strong in TQM, Shop-floor control, 6-sigma, LEAN operation
• Good knowledge in ISO 14971, ISO 62304, IEC 60601, ISO 10993, FDA, GMP, ISO-13485, and their fundamental requirements
• Experience in setting up QMS system under ISO13485, GMP and FDA requirements is preferable
• Must be hands-on and willing to roll up his/her sleeves to get things done
• Able to communicate in English, Cantonese & Mandarin
• Work in Shenzhen factory
• Experience in Healthcare and medical device industry is a plus

This is a challenging opportunity to seek a rewarding career in a fast growing company. Interested parties please send your application letter, CV with expected salary and availability to following