Responsibilities:

• Manage implementation and maintenance of FDA 820 GMP, ISO 13485:2003, ISO 9001 system/documentation for new and existing products
• Select, train and develop QA/QC staff and manage to a high level of team proficiency
• Develop and review quality objectives, inspection specifications and procedures, acceptance criteria/standards
• Manage QA teams for IQC, In-Process Inspection, Final QA and Reliability Testing
• Supervise Supplier Qualification Program, conduct regular supplier Audits and manage KPI system
• Handle and resolve all customer quality-related complaints in a timely manner

Requirements/Qualifications:

• University degree in Engineering or Quality Management or related discipline; appropriate professional certifications
• Excellent knowledge of European and US regulatory standards (RoHS, REACH, FDA, CPSC, etc) and testing/certification standards
• Strong analytical mind in defining problems, gathering data and designing solutions to resolve problems
• Excellent presentation and communication skills and ability to coach and train subordinates
• Good team player, able to take initiative, good planning and organizational skills, dedicated to excellence/success
• Minimum 10 years of experience in QA/QC management in major multi-national or PRC company(s)
• Fluent spoken and written English; must communicate daily with senior management of US and European customers.  Fluent Mandarin.

Position is based in Shenzhen.  The successful candidate will enjoy excellent compensation and fringe benefits.